Clot Removal Methods and Devices with Multiple Independently Controllable Elements

ABSTRACT

A clot removal device for removal of an occlusion from a lumen in a patient&#39;s body is provided. The clot removal device has a lumen, an elongated member positioned within the lumen and extending axially from a proximal end to a distal end of the lumen, a handle attached to the proximal end of the lumen, a first expandable member positioned along a length of the elongated member, a second expandable member positioned along the length of the elongated member, wherein the second expandable member is distal to the first expandable member relative to the handle. The handle has at least one actuation mechanism and at least one of the following applies: a) the first expandable member is coupled to the at least one actuation mechanism and is configured to be moveable relative to the second expandable member upon manipulation of the at least one actuation mechanism; b) the first expandable member is configured to mechanically expand or contract by manipulating the at least one actuation mechanism; c) the second expandable member is coupled to the at least one actuation mechanism and is configured to be moveable relative to the first expandable member upon manipulation of the at least one actuation mechanism; or d) the second expandable member is configured to mechanically expand or contract by manipulating the at least one actuation mechanism.

CROSS-REFERENCE

The present application relies on, for priority, the followingprovisional applications:

U.S. Patent Provisional Application No. 63/260,406, titled “CatheterBased Retrieval Device” and filed on Aug. 19, 2021;

U.S. Patent Provisional Application No. 63/215,724, titled “Device andMethod of Using the Device for Repairing A Pathological ConnectionBetween Two Anatomical Structures” and filed on Jun. 28, 2021;

U.S. Patent Provisional Application No. 63/215,579, titled “Hub andValve Systems for an Aspiration Catheter” and filed on Jun. 28, 2021;

U.S. Patent Provisional Application No. 63/215,573, titled “AspirationCatheters and Methods of Use Thereof” and filed on Jun. 28, 2021; U.S.Patent Provisional Application No. 63/215,587, titled “Vascular ClosureDevices and Methods of Using Thereof” and filed on Jun. 28, 2021;

U.S. Patent Provisional Application No. 63/215,583, titled “Catheterswith Expandable and Collapsible Lumens” and filed on Jun. 28, 2021;

U.S. Patent Provisional Application No. 63/215,565, titled “CatheterBased Retrieval Device” and filed on Jun. 28, 2021; and

U.S. Patent Provisional Application No. 63/092,428, titled “CatheterBased Retrieval Device with Proximal Body Having Axial Freedom ofMovement” and filed on Oct. 15, 2020.

The present application is also a continuation-in-part application ofU.S. patent application Ser. No. 17/127,521, titled “Catheter BasedRetrieval Device with Proximal Body Having Axial Freedom of Movement”and filed on Dec. 18, 2020, which is a continuation application of U.S.patent application Ser. No. 16/205,632, titled “Method to Remove aThrombus”, filed on Nov. 30, 2018, and issued as U.S. Pat. No.10,898,215 on Jan. 26, 2021, which is a divisional application of U.S.patent application Ser. No. 15/953,151, titled “Catheter Based RetrievalDevice with Proximal Body Having Axial Freedom of Movement”, filed onApr. 13, 2018, and issued as U.S. Pat. No. 10,172,634 on Jan. 8, 2019,which, in turn, relies on for priority: U.S. Patent ProvisionalApplication No. 62/653,247 filed on Apr. 5, 2018; U.S. PatentProvisional Application No. 62/589,613, filed on Nov. 22, 2017; U.S.Patent Provisional Application No. 62/606,993, filed on Oct. 16, 2017;and, U.S. Patent Provisional Application No. 62/573,006, filed on Oct.16, 2017.

The present application also relates to U.S. patent application Ser. No.15/953,173, titled “Catheter Based Retrieval Device with Proximal BodyHaving Axial Freedom of Movement”, filed on Apr. 13, 2018 and issued asU.S. Pat. No. 10,258,357 on Apr. 16, 2019, and U.S. patent applicationSer. No. 15/953,186, titled “Catheter Based Retrieval Device withProximal Body Having Axial Freedom of Movement” and filed on Apr. 13,2018, both of which rely on, for priority, the following United StatesPatent Provisional Applications: U.S. Patent Provisional Application No.62/653,247 filed on Apr. 5, 2018; U.S. Patent Provisional ApplicationNo. 62/589,613, filed on Nov. 22, 2017; U.S. Patent ProvisionalApplication No. 62/606,993, filed on Oct. 16, 2017; and, U.S. PatentProvisional Application No. 62/573,006, filed on Oct. 16, 2017.

The present application also relates to PCT Application NumberPCT/US18/55606, titled “Catheter Based Retrieval Device with ProximalBody Having Axial Freedom of Movement” and filed on Oct. 12, 2018, whichclaims the benefit of U.S. patent application Ser. Nos. 15/953,151;15/953,173; 15/953,186, which in turn, claim priority from U.S. PatentProvisional Application No. 62/653,247 filed on Apr. 5, 2018, U.S.Patent Provisional Application No. 62/589,613, filed on Nov. 22, 2017,U.S. Patent Provisional Application No. 62/606,993, filed on Oct. 16,2017, and U.S. Patent Provisional Application No. 62/573,006, filed onOct. 16, 2017.

All of the above-mentioned patents and applications are herebyincorporated by reference in their entirety.

FIELD

The disclosure generally relates to methods and systems for thecatheter-based removal of occlusions and unwanted matter from vessels,ducts and other cavities or lumens of an organism.

BACKGROUND

Current medical devices that are used for the removal of occlusions,such as thrombi from the vessels (such as those in the brain), havelimitations that reduce their effectiveness, reliability, and ease ofuse. For example, current devices are designed exclusively for thevascular system, and may not be used for extraction of material fromducts, ureters, urethra, or other anatomical features. Current devicesare not appropriate for use in large vascular structures such as aorta,vena cava and many peripheral vascular applications, and often do notwork well with calcified, organized material due to inability of thewire structures often used to compress into the embolic material priorto an attempted extraction. Current devices often have a wire structurethat must incorporate into a thrombus to remove a clot and provide poordistal protection from secondary emboli during thrombus extraction dueto open ended stent retriever or partial grasping of thrombus. This mayresult in an intended thrombectomy procedure causing distal clotembolization and occlusion of previously patent arterial branches andcollaterals. Current devices may be less effective when used withassociated arterial stenoses due to device collapse and tendency for astenosis to strip and debride thrombus from device as it is retractedthrough the stenotic vessel segment. Current devices often requireoperators to choose a predetermined device length at time of deviceinsertion, but the chosen device length might not match the size of thetarget thrombus once the operator is in the vessel and provided a closerview of the target thrombus.

Current catheter-based methods and systems for the removal of foreignbodies from an artery, duct, ureter or other interior physical space,often require multiple co-axial (or concentric) sleeves or deliverycatheters, some of which are intended for placement on the proximal sideof an occlusion, some for direction through the occlusion for placementon the distal side of the occlusion, and still others for holdinginflatable balloons, thrombus removal devices and the like. The presenceof multiple catheters increases manufacturing complexity and cost, inaddition to increasing complexity of usage during an intervention, withgreater moving parts and the required ordering of operation aligned withthe function of the multiple catheters. Current catheter-based methodsand systems are also manufactured and deployed in the clinical settingwith a specific catheter, meaning that if during an intervention aclinician wants to deploy (“load”), for example, a retrieval devicehaving a different size than that first deployed in a vessel, the entirecatheter-based tool must be withdrawn and a new catheter-based devicewith the preferred diameter loaded inserted. Additional limitations ofthe current catheter-based systems include, but are not limited to, areliance on fixed-diameter instrumentation and/or inflatable bodies(e.g., balloons) for encapsulation of a foreign body or occlusion. As anexample, catheters using an inflatable balloon for a distal body and/orproximal body may require that an interventionist pre-select a balloonmodel and size prior to entering a vessel or cavity because inflatableballoons have a manufactured minimum and maximum inflation diameter.Thus, if the incorrect balloon size is selected, or the clinical settingrequires flexibility in the expansion or contraction diameter of thedistal or proximal bodies, the intervention may be interrupted to allowfor size adaptation of equipment. Incorrect sizing may also increase thelikelihood for negative clinical sequelae, such as embolization andrelease of occlusive matter if, for example, distal protection is lost.

Additionally, current occlusion removal systems fail to catch or preventsmall portions of a dislodged occlusion from passing through a patient'svessels and possibly causing a thrombosis. Existing devices andtreatment methods permit portions of the occlusion, albeit smaller sizedportions, to pass through the vessel and are not effective at capturingand extracting those portions.

Therefore, there is a need for methods and systems of thrombus, or othermatter, removal in which an object targeted for removal may bedynamically surrounded by a retrieval device, rather than incorporatedinto the target object, wherein the retrieval device can surround thetarget and may be physically adjusted to match the size of the targetobject while within the vessel or other cavity. Further, there is a needfor methods and systems of thrombus, or other matter, removal in which alarger percentage of such matter is captured while not creating anunduly difficult to use or navigate device.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, and not limiting in scope. Thepresent application discloses numerous embodiments.

The present specification discloses a device adapted to remove unwantedmaterial from a vessel of a patient, wherein the device comprises: anelongated member having a first proximal end and a first distal end; aproximal expandable element having a first proximal end point and afirst distal end point, wherein the first proximal end point is attachedto a first portion of the elongated member and wherein the first distalend point is attached to a second portion of the elongated member; adistal expandable element having a second proximal end point and asecond distal end point, wherein the second proximal end point isattached to a third portion of the elongated member, wherein the seconddistal end point is attached to a fourth portion of the elongatedmember, and wherein the first portion, second portion, third portion,and fourth portion represent different locations along the elongatedmember; a handle in physical communication with the elongated member,wherein the handle comprises a first physically manipulable interfaceand a second physically manipulable interface, wherein, when moved, thefirst physically manipulable interface is adapted to mechanically expandor contract the proximal expandable element independent of the distalexpandable element, and wherein, when moved, the second physicallymanipulable interface is adapted to mechanically expand or contract thedistal expandable element independent of the proximal expandableelement.

Optionally, the handle further comprises a third physically manipulableinterface and wherein, when moved, the third physically manipulableinterface is adapted to move the proximal expandable element while thedistal expandable element remains stationary. Optionally, the thirdphysically manipulable interface is a slider configured to be movedaxially along a length of the handle wherein, upon moving the slideraxially along the length, the proximal expandable element moves whilethe distal expandable element remains stationary.

Optionally, the handle further comprises a third physically manipulableinterface wherein, when moved, the third physically manipulableinterface is adapted to move the distal expandable element while theproximal expandable element remains stationary. Optionally, the thirdphysically manipulable interface is a slider configured to be movedaxially along a length of the handle wherein, upon moving the slideraxially along the length, the distal expandable element moves while theproximal expandable element remains stationary.

Optionally, the first physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the proximal expandableelement expands or contracts.

Optionally, the second physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the distal expandableelement expands or contracts.

Optionally, the proximal expandable element comprises a braid having aproximal portion and a distal portion, wherein the braid of the proximalportion is denser or stiffer relative to the braid of the distalportion. Optionally, the proximal portion represents 30-70% of thesurface area of the proximal expandable element and the distal portionrepresents 70-30% of the surface area of the proximal expandableelement.

Optionally, the distal expandable element comprises a braid having aproximal portion and a distal portion, wherein the braid of the distalportion is denser or stiffer relative to the braid of the proximalportion. Optionally, the distal portion represents 30-70% of the surfacearea of the distal expandable element and the proximal portionrepresents 70-30% of the surface area of the distal expandable element.

Optionally, the proximal expandable element is defined by a first braidstructure and the distal expandable element is defined by a second braidstructure, wherein the second braid structure is equivalent to the firstbraid structure.

Optionally, the proximal expandable element is defined by a first braidstructure and the distal expandable element is defined by a second braidstructure, wherein the second braid structure is equivalent to the firstbraid structure rotated 180 degrees.

Optionally, the device further comprises a hub valve and a sheath,wherein the hub valve is defined by an enclosure, a first opening in afirst end of the enclosure, a second opening in a second end of theenclosure, and an actuator extending upward out of the enclosure whereinthe sheath is coupled to the second opening. Optionally, when theactuator is depressed, the hub valve is configured to receive theelongated member through the first opening and allow the elongatedmember to pass through the second opening and through the sheath.Optionally, when the actuator is not depressed, the hub valve isconfigured to create a seal around a surface of the elongated member.Optionally, the device further comprises a suction source coupled to aportion of the hub and in pressure communication with the sheath.Optionally, the suction source is a syringe.

Optionally, the handle further comprises a pin positioned to block amovement of the first physically manipulable interface and the secondphysically manipulable interface, a keyhole accessible from a side ofthe handle, and a key configured to pass into the keyhole and makephysical contact with the pin.

Optionally, the elongated member comprises a first shaft, a secondshaft, a third shaft, and a fourth shaft wherein the first shaft isconcentrically positioned around the second shaft, the second shaft isconcentrically positioned around the third shaft, and the third shaft isconcentrically positioned around the fourth shaft. Optionally, the firstproximal end point is physically attached to the first shaft, the firstdistal end point is physically attached to the second shaft, the secondproximal end point is physically attached to the third shaft, and thesecond distal end point is physically attached to the fourth shaft.Optionally, the first physically manipulable interface is configured toaxially move the first shaft while the second shaft, third shaft, andfourth shaft remain stationary. Optionally, the first physicallymanipulable interface is a slider configured to move axially up and downthe handle. Optionally, the second physically manipulable interface isconfigured to axially move the fourth shaft while the first shaft,second shaft, and third shaft remain stationary. Optionally, the secondphysically manipulable interface is a slider configured to move axiallyup and down the handle. Optionally, the device further comprises a thirdphysically manipulable interface, wherein the third physicallymanipulable interface is configured to axially move the first shaft andsecond shaft together while the third shaft and fourth shaft remainstationary. Optionally, the third physically manipulable interface is aslider configured to move axially up and down the handle.

Optionally, the first physically manipulable interface is configured toaxially move the first portion to one of a first plurality of predefinedincremented positions while the second portion, third portion, andfourth portion remain stationary, wherein each of the first plurality ofpredefined incremented positions corresponds to causing the proximalexpandable element to adopt one of a plurality of different geometricshapes, and wherein the plurality of different geometric shapes includesat least two of linear, ellipsoid, spheroid, spherical or disk-shaped.Optionally, the second physically manipulable interface is configured toaxially move the fourth portion to one of a second plurality ofpredefined incremented positions while the first portion, secondportion, and third portion remain stationary and each of the secondplurality of predefined incremented positions corresponds to causing thedistal expandable element to adopt one of the plurality of differentgeometric shapes. Optionally, upon adopting one of the plurality ofdifferent geometric shapes other than the linear shape, the proximalexpandable element or distal expandable element is adapted to notcollapse upon an application of up to 25 Newtons of force.

The present specification also discloses a device adapted to removeunwanted material from a vessel of a patient, wherein the devicecomprises: an elongated member having a first proximal end and a firstdistal end; a proximal expandable element having a first proximal endpoint and a first distal end point, wherein the first proximal end pointis attached to a first portion of the elongated member and wherein thefirst distal end point is attached to a second portion of the elongatedmember; a distal expandable element having a second proximal end pointand a second distal end point, wherein the second proximal end point isattached to a third portion of the elongated member, wherein the seconddistal end point is attached to a fourth portion of the elongatedmember, and wherein the first portion, second portion, third portion,and fourth portion represent different locations along the elongatedmember; a handle in physical communication with the elongated member,wherein the handle comprises a first physically manipulable interfaceand a second physically manipulable interface, wherein, when moved, thefirst physically manipulable interface is adapted to mechanically expandor contract at least one of the proximal expandable element or thedistal expandable element and wherein, when moved, the second physicallymanipulable interface is adapted to move the proximal expandable elementwithout moving the distal expandable element or move the distalexpandable element without moving the proximal expandable element.

Optionally, when moved, the first physically manipulable interface isadapted to mechanically expand or contract the proximal expandableelement. Optionally, the device further comprises a third physicallymanipulable interface, wherein, when moved, the third physicallymanipulable interface is adapted to mechanically expand or contract thedistal expandable element.

Optionally, the second physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the proximal expandableelement moves while the distal expandable element remains stationary.

Optionally, the second physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the distal expandableelement moves while the proximal expandable element remains stationary.

Optionally, the first physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the proximal expandableelement expands or contracts while a size of the distal expandableelement does not change.

Optionally, the first physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle wherein,upon moving the slider axially along the length, the distal expandableelement expands or contracts while a size of the proximal expandableelement does not change.

Optionally, the proximal expandable element comprises a braid having aproximal portion and a distal portion, wherein the braid of the proximalportion is denser or stiffer relative to the braid of the distalportion. Optionally, the proximal portion represents 30-70% of thesurface area of the proximal expandable element and the distal portionrepresents 70-30% of the surface area of the proximal expandableelement.

Optionally, the distal expandable element comprises a braid having aproximal portion and a distal portion, wherein the braid of the distalportion is denser or stiffer relative to the braid of the proximalportion. Optionally, the distal portion represents 30-70% of the surfacearea of the distal expandable element and the proximal portionrepresents 70-30% of the surface area of the distal expandable element.

Optionally, the proximal expandable element is defined by a first braidstructure and the distal expandable element is defined by a second braidstructure, wherein the second braid structure is equivalent to the firstbraid structure.

Optionally, the proximal expandable element is defined by a first braidstructure and the distal expandable element is defined by a second braidstructure, wherein the second braid structure is equivalent to the firstbraid structure rotated 180 degrees.

Optionally, the device further comprises a hub valve and a sheath,wherein the hub valve is defined by an enclosure, a first opening in afirst end of the enclosure, a second opening in a second end of theenclosure, and an actuator extending upward out of the enclosure whereinthe sheath is coupled to the second opening. Optionally, when theactuator is depressed, the hub valve is configured to receive theelongated member through the first opening and allow the elongatedmember to pass through the second opening and through the sheath.Optionally, when the actuator is not depressed, the hub valve isconfigured to create a seal around a surface of the elongated member.Optionally, the device further comprises a suction source coupled to aportion of the hub and in pressure communication with the sheath.Optionally, the suction source is a syringe.

Optionally, the handle further comprises a pin positioned to block amovement of the first physically manipulable interface and the secondphysically manipulable interface, a keyhole accessible from a side ofthe handle, and a key configured to pass into the keyhole and makephysical contact with the pin.

Optionally, the elongated member comprises a first shaft, a secondshaft, a third shaft, and a fourth shaft wherein the first shaft isconcentrically positioned around the second shaft, the second shaft isconcentrically positioned around the third shaft, and the third shaft isconcentrically positioned around the fourth shaft. Optionally, the firstproximal end point is physically attached to the first shaft, the firstdistal end point is physically attached to the second shaft, the secondproximal end point is physically attached to the third shaft, and thesecond distal end point is physically attached to the fourth shaft.Optionally, the first physically manipulable interface is configured toaxially move the first shaft while the second shaft, third shaft, andfourth shaft remain stationary. Optionally, the first physicallymanipulable interface is a slider configured to move axially up and downthe handle. Optionally, the first physically manipulable interface isconfigured to axially move the fourth shaft while the first shaft,second shaft, and third shaft remain stationary. Optionally, the firstphysically manipulable interface is a slider configured to move axiallyup and down the handle. Optionally, the second physically manipulableinterface is configured to axially move the first shaft and second shafttogether while the third shaft and fourth shaft remain stationary.Optionally, the second physically manipulable interface is a sliderconfigured to move axially up and down the handle.

Optionally, the first physically manipulable interface is configured toaxially move the first portion to one of a first plurality of predefinedincremented positions while the second portion, third portion, andfourth portion remain stationary, wherein each of the first plurality ofpredefined incremented positions corresponds to causing the proximalexpandable element to adopt one of a plurality of different geometricshapes, and wherein the plurality of different geometric shapes includesat least two of linear, ellipsoid, spheroid, spherical or disk-shaped.

Optionally, the first physically manipulable interface is configured toaxially move the fourth portion to one of a second plurality ofpredefined incremented positions while the first portion, secondportion, and third portion remain stationary, wherein each of the secondplurality of predefined incremented positions corresponds to causing thedistal expandable element to adopt one of the plurality of differentgeometric shapes. Optionally, upon adopting one of the plurality ofdifferent geometric shapes other than the linear shape, the distalexpandable element is adapted to not collapse upon an application of upto 25 Newtons of force.

In some embodiments, the present specification also discloses a devicefor removing an occlusion from a lumen within a patient's body,comprising: a handle having a distal end, wherein the distal end iscoupled to a proximal end of a tip portion through one or moretelescoping tubes, wherein the handle includes at least one actuationmechanism; and an element mounted at the tip portion, wherein theelement is in a first state, wherein the handle is configured to steerthe tip portion through the lumen so that the element is positionedwithin the occlusion, wherein the at least one actuation mechanism ismanipulated in a first direction to transition the element from thefirst state to a second state within the occlusion, and wherein theelement in the second state is imparted one or more fore and aft motionsto dislodge and scrape the occlusion.

Optionally, the first state corresponds to the element being in acontracted configuration and the second state corresponds to the elementbeing in an expanded configuration.

Optionally, the at least one actuation mechanism includes first andsecond knobs, wherein the first knob is manipulated to transition theelement from the first state to the second state, and wherein the secondknob is manipulated to impart the one or more fore and aft motions tothe element relative to the tip portion.

Optionally, the handle is moved fore and aft to cause the tip portionand therefore the element to be moved fore and aft.

Optionally, the at least one actuation mechanism includes a knob that ismanipulated to transition the element from the first state to the secondstate.

Optionally, the device further includes a delivery catheter and anaspiration catheter, wherein the tip portion is positioned within thedelivery catheter and the delivery catheter is positioned within theaspiration catheter, and wherein a negative pressure is applied at aproximal end of the aspiration catheter to aspirate the dislodged andscraped occlusion.

Optionally, the at least one actuation mechanism is manipulated in asecond direction opposite to the first direction to transition theelement from the second state to the first state, and wherein the handleis used to retract the element in the first state from the lumen.

Optionally, the element has proximal, distal and center portions,wherein the proximal portion is shaped as a first funnel having a firstneck directed proximally along a longitudinal axis of the tip portionand the distal portion is shaped as a second funnel having a second neckdirected distally along the longitudinal axis, wherein respective cupedges of the first and second funnels are attached across a central axisto form the center portion, said central axis lying approximatelyorthogonal to the longitudinal axis.

Optionally, the element has a three-dimensional geometric shape in thesecond state, and wherein the three dimensional geometric shape is oneor a combination of spherical, elliptical, conical, polygonal,cylindrical, stent, chalice cup, umbrella, concave, convex, half-sphere,sphere, windsock, dumbbell, star, polygon, or lever shapes.

In some embodiments, the present specification discloses a method ofusing a device to remove an occlusion from a lumen within a patient'sbody, wherein the device comprises a handle coupled to a proximal end ofa tip portion through one or more telescoping tubes, and an elementmounted on the tip portion, and wherein the element is in a first state,the method comprising: positioning the tip portion through a deliverycatheter; positioning the delivery catheter through an aspirationcatheter; steering, using the handle, the tip portion through the lumenso that the element is positioned within the occlusion; transitioning,by manipulating at least one actuation mechanism on the handle in afirst direction, the element from the first state to a second state; andimparting one or more fore and aft motions to the element in order todislodge and scrape the occlusion. Optionally, the first statecorresponds to the element being in a contracted configuration and thesecond state corresponds to the element being in an expandedconfiguration.

Optionally, the at least one actuation mechanism includes first andsecond knobs, wherein the first knob is manipulated to transition theelement from the first state to the second state, and wherein the secondknob is manipulated to impart the one or more fore and aft motions tothe element relative to the tip portion.

Optionally, the handle is moved fore and aft to cause the tip portionand therefore the element to be moved fore and aft.

Optionally, the at least one actuation mechanism includes a knob that ismanipulated to transition the element from the first state to the secondstate.

Optionally, the method further comprises applying a negative pressure ata proximal end of the aspiration catheter to aspirate the dislodged andscraped occlusion.

Optionally, the method further comprises transitioning, by manipulatingthe at least one actuation mechanism on the handle in a second directionopposite to the first direction, the element from the second state tothe first state; and retracting, using the handle, the element in thefirst state from the lumen.

Optionally, the element has proximal, distal and center portions,wherein the proximal portion is shaped as a first funnel having a firstneck directed proximally along a longitudinal axis of the tip portionand the distal portion is shaped as a second funnel having a second neckdirected distally along the longitudinal axis, wherein respective cupedges of the first and second funnels are attached across a central axisto form the center portion, said central axis lying approximatelyorthogonal to the longitudinal axis.

Optionally, the element has a three-dimensional geometric shape in thesecond state, and wherein the three-dimensional geometric shape is oneor a combination of spherical, elliptical, conical, polygonal,cylindrical, stent, chalice cup, umbrella, concave, convex, half-sphere,sphere, windsock, dumbbell, star, polygon, or lever shapes.

In some embodiments, the present specification discloses a device forremoving clot from a lumen within a patient's body, comprising: a handlehaving a distal end, wherein the distal end is coupled to a proximal endof a tip portion through one or more telescoping tubes, wherein thehandle includes at least one actuation mechanism; and an element mountedat the tip portion, wherein the element is in a first state, wherein thehandle is configured to steer the tip portion through the lumen so thatthe element is positioned within the clot, wherein the at least oneactuation mechanism is manipulated in a first direction to transitionthe element from the first state to a second state and from the secondstate to a third state within the clot, and wherein the element in thesecond state and/or the third state is imparted one or more fore and aftmotions to dislodge and scrape the clot.

Optionally, the second state corresponds to a first radial force that afirst size of the element applies to the clot and the third statecorresponds to a second radial force that a second size of the elementapplies to the clot, and wherein the second radial force is differentfrom the first radial force.

Optionally, each of the first and second radial force is in a range of 2Newtons to 20 Newtons.

In some embodiments, the present specification discloses a clot removaldevice comprising: a lumen having a proximal end, a distal end, and alength extending between the proximal end and the distal end; anelongated member positioned within the lumen and extending axially fromthe proximal end to the distal end; a handle attached to the proximalend of the lumen, wherein the handle comprises at least one actuationmechanism; a first expandable member positioned along a length of theelongated member; and a second expandable member positioned along thelength of the elongated member, wherein the second expandable member isdistal to the first expandable member relative to the handle and whereinat least one of: i) the first expandable member is coupled to the atleast one actuation mechanism and is configured to be moveable relativeto the second expandable member upon manipulation of the at least oneactuation mechanism; ii) the first expandable member is configured tomechanically expand or contract by manipulating the at least oneactuation mechanism; iii) the second expandable member is coupled to theat least one actuation mechanism and is configured to be moveablerelative to the first expandable member upon manipulation of the atleast one actuation mechanism; or iii) the second expandable member isconfigured to mechanically expand or contract by manipulating the atleast one actuation mechanism.

Optionally, the handle comprises at least two actuation mechanisms,wherein the first expandable member is coupled to a first of the atleast two actuation mechanisms and is configured to be moveable relativeto the second expandable member upon manipulation of the first of the atleast two actuation mechanisms and wherein the first expandable memberis further configured to mechanically expand or contract by manipulatinga second of the at least two actuation mechanisms.

Optionally, a first of the at least two actuation mechanisms comprises afirst sliding member accessible on an external surface of the handle,wherein the first sliding member is coupled to a first internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the first sliding member, the firstinternal member moves axially to cause the first expandable member tomove relative to the second expandable member.

Optionally, the first internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a second of the at least two actuation mechanisms comprisesa second sliding member accessible on an external surface of the handle,wherein the second sliding member is coupled to a second internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the second sliding member, thesecond internal member moves axially to cause the first expandablemember to mechanically expand or contract.

Optionally, the second internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, the first sliding member and the second sliding member arepositioned adjacent each other and distributed circumferentially aroundthe external surface of the handle.

Optionally, the handle comprises at least three actuation mechanisms,wherein the first expandable member is coupled to a first of the atleast two actuation mechanisms and is configured to be moveable relativeto the second expandable member upon manipulation of the first of the atleast two actuation mechanisms, wherein the first expandable member isfurther configured to mechanically expand or contract by manipulating asecond of the at least two actuation mechanisms, and wherein the secondexpandable member is further configured to mechanically expand orcontract by manipulating a third of the at least two actuationmechanisms.

Optionally, a first of the at least two actuation mechanisms comprises afirst sliding member accessible on an external surface of the handle,wherein the first sliding member is coupled to a first internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the first sliding member, the firstinternal member moves axially to cause the first expandable member tomove relative to the second expandable member.

Optionally, the first internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a second of the at least two actuation mechanisms comprisesa second sliding member accessible on an external surface of the handle,wherein the second sliding member is coupled to a second internal memberpositioned in the lumen and configured to move axially along the lengthof the handle, and wherein, upon moving the second sliding member, thesecond internal member moves axially to cause the first expandablemember to mechanically expand or contract.

Optionally, the second internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a third of the at least two actuation mechanisms comprises athird sliding member accessible on an external surface of the handle,wherein the third sliding member is coupled to a third internal memberpositioned in the lumen and configured to move axially along the lengthof the handle, and wherein, upon moving the third sliding member, thethird internal member moves axially to cause the second expandablemember to mechanically expand or contract. Optionally, the thirdinternal member is at least one of a wire, tube, or cylinder coupled toa portion of the second expandable member. Optionally, the first slidingmember, the second sliding member, and the third sliding member arepositioned adjacent each other and distributed circumferentially aroundthe external surface of the handle.

Optionally, the first expandable member is coupled to the at least oneactuation mechanism and is configured to be moveable relative to thesecond expandable member upon manipulation of the at least one actuationmechanism while a position of the second expandable member is notaffected by the manipulation of the at least one actuation mechanism.

Optionally, the first expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanismwhile a size of the second expandable member is not affected by themanipulation of the at least one actuation mechanism.

Optionally, the second expandable member is coupled to the at least oneactuation mechanism and is configured to be moveable relative to thefirst expandable member upon manipulation of the at least one actuationmechanism while a position of the first expandable member is notaffected by the manipulation of the at least one actuation mechanism.

Optionally, the second expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanismwhile a size of the first expandable member is not affected by themanipulation of the at least one actuation mechanism.

Optionally, at least one of the first expandable member or the secondexpandable member expands upon moving the at least one actuationmechanism distally and wherein said expansion causes at least one of thefirst expandable member and the second expandable member to transformfrom a substantially linear configuration to a first shape, second shapeor third shape depending on how far the at least one actuation mechanismhas been moved distally.

Optionally, the first shape, second shape or third shape is at least oneof a spherical shape, an elliptical shape, a conical shape, a polygonalshape, a cylindrical shape, a shape of a stent, a shape of a chalicecup, a shape of an umbrella, a concave shape, a convex shape, ahalf-sphere shape, a windsock shape, a dumbbell shape, a star shape, orany combination of said shapes.

Optionally, the first shape has a first outer surface and wherein afurthest distance from the first outer surface to the elongated memberis defined by a first distance, wherein the second shape has a secondouter surface and wherein a furthest distance from the second outersurface to the elongated member is defined by a second distance, whereinthe third shape has a third outer surface, wherein a furthest distancefrom the third outer surface to the elongated member is defined by athird distance, wherein the third distance is greater than the seconddistance and wherein the second distance is greater than the firstdistance.

Optionally, the first shape is configured to maintain said firstdistance even upon an application of a first external force to the firstouter surface in a range of 9 newtons to 15 newtons, wherein the secondshape is configured to maintain said second distance even upon anapplication of a second external force to the second outer surface in arange of 9 newtons to 15 newtons, and wherein the third shape isconfigured to maintain said third distance even upon an application of athird external force to the third outer surface in a range of 9 newtonsto 15 newtons.

Optionally, the first shape is configured to collapse upon applicationof a force that is greater than the first external force, wherein thesecond shape is configured to collapse upon application of a force thatis greater than the second external force, wherein the third shape isconfigured to collapse upon application of a force that is greater thanthe third external force, wherein the first external force is less thanthe second external force which is less than the third external force.

Optionally, upon expansion, at least one of the first expandable memberor the second expandable member has an amount of open surface arearelative to an amount of total surface area in a range of 1% to 99%.

Optionally, upon expansion, the first expandable member has a greateramount of the open surface area relative to the amount of the totalsurface area than the second expandable member.

Optionally, the at least one actuation mechanism is a slider, a knob, alever, a dial or a push button.

Optionally, at least one of the first expandable member or the secondexpandable member is a braided structure that transforms from a firstconfiguration that is an elongated braided structure positionedcircumferentially around and parallel to the elongated member into asecond configuration.

Optionally, the second configuration comprises a first braided structurethat is defined by a cone having a first curved face that revolvesaround the periphery of the base at a first end and narrows into a firstplurality of points on the elongated member at an opposing end and asecond braided structure integrally formed with the first braidedstructure and defined by a cone having a second curved face thatrevolves around the periphery of the base at one end and narrows into asecond plurality of points on the elongated member at an opposing end,wherein the first plurality of points and second plurality of points areseparated along the length of the elongated member.

Optionally, the second configuration is a sphere shape, ellipticalshape, a diamond shape, a polygonal shape, or a bicone.

Optionally, at least one of the first expandable member or the secondexpandable member is configured to expand using the at least oneactuation member using no more than one moving member.

In some embodiments, the present specification discloses a clot removalmethod using a clot removal device, wherein the clot removal devicecomprises a catheter having a lumen, a proximal end, a distal end, and alength extending between the proximal end and the distal end, anelongated member positioned within the lumen and extending axially fromthe proximal end to the distal end, a handle attached to the proximalend of the lumen, a first expandable member positioned along a length ofthe elongated member, and a second expandable member positioned alongthe length of the elongated member, wherein the handle comprises a firstactuation mechanism, a second actuation mechanism, a third actuationmechanism and wherein the second expandable member is distal to thefirst expandable member relative to the handle, and wherein the methodcomprises: introducing a wire through a patient and positioning the wireproximate a clot; positioning the catheter into the patient, over thewire, and proximate the clot; extending the second expandable member outof the lumen and into the clot or distal to the clot by manipulating theelongated member; extending the first expandable member out of the lumenand into the clot or proximal to the clot by manipulating the elongatedmember; using at least one of the first actuation mechanism or thesecond actuation mechanism, expanding the second expandable member;using at least one of the first actuation mechanism or the secondactuation mechanism, expanding the first expandable member; using thethird actuation mechanism, axially moving the first expandable membertoward an opening in the lumen; using at least one of the firstactuation mechanism or the second actuation mechanism, compressing thefirst expandable member; using at least one of the first actuationmechanism or the second actuation mechanism, compressing the secondexpandable member; pulling the first expandable member and the secondexpandable member into the lumen; and removing the catheter from thepatient.

Optionally, the method includes axially moving the first expandablemember back and forth along said length using the third actuationmechanism.

Optionally, the method includes axially moving the first expandablemember toward an opening in the lumen and subsequently applying suctionto said lumen using the third actuation mechanism.

Optionally, the method further comprises applying suction to the lumen.

Optionally, the first expandable member is configured to be moveablerelative to the second expandable member while the second expandablemember remains stationary.

Optionally, the second expandable member is configured to be moveablerelative to the first expandable member while the first expandablemember remains stationary.

Optionally, the first expandable member is configured to mechanicallyexpand or contract without affecting a size, dimension or shape of thesecond expandable member.

Optionally, the second expandable member is configured to mechanicallyexpand or contract without affecting a size, dimension or shape of thefirst expandable member.

In some embodiments, the present specification discloses a medicalretrieval device for removal of an occlusion from a lumen in a patient'sbody comprising: a handle comprising a groove running longitudinallythrough a length of the handle; a delivery catheter comprising a tipportion coupled to the handle, wherein the handle is configured to steerthe tip portion in proximity to the occlusion; an expandable distalelement fixedly attached to a distal end of the tip portion, wherein thedistal element is configured as a cup; and, a pusher slidably mountednear a proximal end of the tip portion, wherein the pusher is movablerelative to the distal element and adapted to remove the occlusion byplacement of the occlusion in the cup.

Optionally, the device further comprises a distal element expandercoupled with a distal element anchor tube, wherein the distal elementexpander is slidably fitted into the groove, and wherein sliding theexpander in the groove towards the distal element causes the distalelement to expand. Optionally, the expander locks in a position in thegroove when the distal element has expanded to a maximum diameter.

Optionally, a shape of the pusher ball when expanded is spherical havinga maximum diameter of 20 mm.

Optionally, the distal element anchor tube is a Nitinol tube connectedto the distal element for aiding in the expansion of the distal element.

Optionally, the device further comprises a pusher ball expander and apusher ball slider slidably fitted into the groove, wherein the pusherball expander when moved in the groove towards the pusher causes thepusher to expand; and wherein the pusher ball slider moves synchronouslywith the pusher ball expander towards the distal element and in anopposing direction towards the handle one or more times for dislodgingthe occlusion and placing the occlusion in the distal element.

Optionally, a shape of the pusher when expanded is spherical having amaximum diameter of 18 mm.

Optionally, the pusher ball expander locks in a position in the groovewhen the pusher ball has expanded to a maximum diameter.

Optionally, the tip portion comprises a plurality of flexible elementsaiding in the expansion of the distal element and the pusher.

Optionally, the flexible elements comprise four co-axial telescopictubes movable relative to each other by using the handle, the relativemovement causing expansion and compression of the distal element and thepusher.

Optionally, the distal element is rigid and holds a predefined shapeafter expansion.

Optionally, the handle comprises an aspiration line to aspirate theocclusion after said occlusion is placed in the distal element.

In some embodiments, the present specification discloses a method ofremoval of an occlusion from a lumen in a patient's body by using amedical retrieval device comprising at least a handle comprising agroove running longitudinally through a length of the handle; a deliverycatheter comprising a tip portion coupled to the handle; an expandablerigid anchor fixedly attached to a distal end of the tip; and a pusherball slidably mounted near a proximal end of the tip, the methodcomprising: steering the tip in proximity to the occlusion by using thehandle; expanding the pusher ball and the rigid anchor; moving thepusher ball longitudinally along the wire one or more times to dislodgethe occlusion and capture the occlusion between the pusher ball and therigid anchor; and removing the captured occlusion by pulling out thepusher ball, occlusion and rigid anchor together from the lumen of thepatient.

Optionally, the rigid anchor is a wire mesh structure, and ismechanically expanded.

Optionally, the rigid anchor is anchored at a distal end of the tip anda pusher on the handle of the retriever is used to cause the wire meshstructure to expand out from the delivery catheter running through acenter of the rigid anchor.

Optionally, the rigid anchor is fixed in a predefined position allowingfor the pusher ball to move back and forth longitudinally on the wirewith respect to the rigid anchor to dislodge the occlusion.

Optionally, the rigid anchor is expanded within the occlusion.

Optionally, the rigid anchor is expanded after driving the tip throughthe occlusion and positioning the rigid anchor distal to the occlusion.

Optionally, the pusher ball is expanded within the occlusion, such thatthe pusher ball moves all the way into the rigid anchor for capturingthe occlusion within the rigid anchor.

Optionally, removing the captured occlusion comprises moving the pusherball relative to the rigid anchor.

In some embodiments, the present specification discloses a clot removaldevice comprising: a lumen having a proximal end, a distal end, and alength extending between the proximal end and the distal end; anelongated member positioned within the lumen and extending axially fromthe proximal end to the distal end; a handle attached to the proximalend of the lumen, wherein the handle comprises at least one actuationmechanism; a first expandable member positioned along a length of theelongated member; and a second expandable member positioned along thelength of the elongated member, wherein the second expandable member isdistal to the first expandable member relative to the handle and whereinat least one of: the first expandable member is coupled to the at leastone actuation mechanism and is configured to be moveable relative to thesecond expandable member upon manipulation of the at least one actuationmechanism; the first expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanism;the second expandable member is coupled to the at least one actuationmechanism and is configured to be moveable relative to the firstexpandable member upon manipulation of the at least one actuationmechanism; or the second expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanism.

Optionally, the handle comprises at least two actuation mechanisms,wherein the first expandable member is coupled to a first of the atleast two actuation mechanisms and is configured to be moveable relativeto the second expandable member upon manipulation of the first of the atleast two actuation mechanisms and wherein the first expandable memberis further configured to mechanically expand or contract by manipulatinga second of the at least two actuation mechanisms.

Optionally, a first of the at least two actuation mechanisms comprises afirst sliding member accessible on an external surface of the handle,wherein the first sliding member is coupled to a first internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the first sliding member, the firstinternal member moves axially to cause the first expandable member tomove relative to the second expandable member.

Optionally, the first internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a second of the at least two actuation mechanisms comprisesa second sliding member accessible on an external surface of the handle,wherein the second sliding member is coupled to a second internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the second sliding member, thesecond internal member moves axially to cause the first expandablemember to mechanically expand or contract.

Optionally, the second internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, the first sliding member and the second sliding member arepositioned adjacent each other and distributed circumferentially aroundthe external surface of the handle.

Optionally, the handle comprises at least three actuation mechanisms,wherein the first expandable member is coupled to a first of the atleast two actuation mechanisms and is configured to be moveable relativeto the second expandable member upon manipulation of the first of the atleast two actuation mechanisms, wherein the first expandable member isfurther configured to mechanically expand or contract by manipulating asecond of the at least two actuation mechanisms, and wherein the secondexpandable member is further configured to mechanically expand orcontract by manipulating a third of the at least two actuationmechanisms.

Optionally, a first of the at least two actuation mechanisms comprises afirst sliding member accessible on an external surface of the handle,wherein the first sliding member is coupled to a first internal memberpositioned in the lumen and configured to move axially along a length ofthe handle, and wherein, upon moving the first sliding member, the firstinternal member moves axially to cause the first expandable member tomove relative to the second expandable member.

Optionally, the first internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a second of the at least two actuation mechanisms comprisesa second sliding member accessible on an external surface of the handle,wherein the second sliding member is coupled to a second internal memberpositioned in the lumen and configured to move axially along the lengthof the handle, and wherein, upon moving the second sliding member, thesecond internal member moves axially to cause the first expandablemember to mechanically expand or contract.

Optionally, the second internal member is at least one of a wire, tube,or cylinder coupled to a portion of the first expandable member.

Optionally, a third of the at least two actuation mechanisms comprises athird sliding member accessible on an external surface of the handle,wherein the third sliding member is coupled to a third internal memberpositioned in the lumen and configured to move axially along the lengthof the handle, and wherein, upon moving the third sliding member, thethird internal member moves axially to cause the second expandablemember to mechanically expand or contract.

Optionally, the third internal member is at least one of a wire, tube,or cylinder coupled to a portion of the second expandable member.

Optionally, the first sliding member, the second sliding member, and thethird sliding member are positioned adjacent each other and distributedcircumferentially around the external surface of the handle.

Optionally, the first expandable member is coupled to the at least oneactuation mechanism and is configured to be moveable relative to thesecond expandable member upon manipulation of the at least one actuationmechanism while a position of the second expandable member is notaffected by the manipulation of the at least one actuation mechanism.

Optionally, the first expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanismwhile a size of the second expandable member is not affected by themanipulation of the at least one actuation mechanism.

Optionally, the second expandable member is coupled to the at least oneactuation mechanism and is configured to be moveable relative to thefirst expandable member upon manipulation of the at least one actuationmechanism while a position of the first expandable member is notaffected by the manipulation of the at least one actuation mechanism.

Optionally, the second expandable member is configured to mechanicallyexpand or contract by manipulating the at least one actuation mechanismwhile a size of the first expandable member is not affected by themanipulation of the at least one actuation mechanism.

Optionally, at least one of the first expandable member or the secondexpandable member expands upon moving the at least one actuationmechanism distally and wherein said expansion causes at least one of thefirst expandable member and the second expandable member to transformfrom a substantially linear configuration to a first shape, second shapeor third shape depending on how far the at least one actuation mechanismhas been moved distally.

Optionally, the first shape, second shape or third shape is at least oneof a spherical shape, an elliptical shape, a conical shape, a polygonalshape, a cylindrical shape, a shape of a stent, a shape of a chalicecup, a shape of an umbrella, a concave shape, a convex shape, ahalf-sphere shape, a windsock shape, a dumbbell shape, a star shape, orany combination of said shapes.

Optionally, the first shape has a first outer surface and wherein afurthest distance from the first outer surface to the elongated memberis defined by a first distance, wherein the second shape has a secondouter surface and wherein a furthest distance from the second outersurface to the elongated member is defined by a second distance, whereinthe third shape has a third outer surface, wherein a furthest distancefrom the third outer surface to the elongated member is defined by athird distance, wherein the third distance is greater than the seconddistance and wherein the second distance is greater than the firstdistance.

Optionally, the first shape is configured to maintain said firstdistance even upon an application of a first external force to the firstouter surface in a range of 9 newtons to 15 newtons, wherein the secondshape is configured to maintain said second distance even upon anapplication of a second external force to the second outer surface in arange of 9 newtons to 15 newtons, and wherein the third shape isconfigured to maintain said third distance even upon an application of athird external force to the third outer surface in a range of 9 newtonsto 15 newtons.

Optionally, the first shape is configured to collapse upon applicationof a force that is greater than the first external force, wherein thesecond shape is configured to collapse upon application of a force thatis greater than the second external force, wherein the third shape isconfigured to collapse upon application of a force that is greater thanthe third external force, wherein the first external force is less thanthe second external force which is less than the third external force.

Optionally, upon expansion, at least one of the first expandable memberor the second expandable member has an amount of open surface arearelative to an amount of total surface area in a range of 1% to 99%.

Optionally, upon expansion, the first expandable member has a greateramount of the open surface area relative to the amount of the totalsurface area than the second expandable member.

Optionally, the at least one actuation mechanism is a slider, a knob, alever, a dial or a push button.

Optionally, at least one of the first expandable member or the secondexpandable member is a braided structure that transforms from a firstconfiguration that is an elongated braided structure positionedcircumferentially around and parallel to the elongated member into asecond configuration.

Optionally, the second configuration comprises a first braided structurethat is defined by a cone having a first curved face that revolvesaround the periphery of the base at a first end and narrows into a firstplurality of points on the elongated member at an opposing end and asecond braided structure integrally formed with the first braidedstructure and defined by a cone having a second curved face thatrevolves around the periphery of the base at one end and narrows into asecond plurality of points on the elongated member at an opposing end,wherein the first plurality of points and second plurality of points areseparated along the length of the elongated member.

Optionally, the second configuration is a sphere shape, ellipticalshape, a diamond shape, a polygonal shape, or a bi-cone.

Optionally, at least one of the first expandable member or the secondexpandable member is configured to expand using the at least oneactuation member using no more than one moving member.

In some embodiments, the present specification discloses a clot removalmethod using a clot removal device, wherein the clot removal devicecomprises a catheter having a lumen, a proximal end, a distal end, and alength extending between the proximal end and the distal end, anelongated member positioned within the lumen and extending axially fromthe proximal end to the distal end, a handle attached to the proximalend of the lumen, a first expandable member positioned along a length ofthe elongated member, and a second expandable member positioned alongthe length of the elongated member, wherein the handle comprises a firstactuation mechanism, a second actuation mechanism, a third actuationmechanism and wherein the second expandable member is distal to thefirst expandable member relative to the handle, and wherein the methodcomprises: introducing a wire through a patient and positioning the wireproximate a clot; positioning the catheter into the patient, over thewire, and proximate the clot; extending the second expandable member outof the lumen and into the clot or distal to the clot by manipulating theelongated member; extending the first expandable member out of the lumenand into the clot or proximal to the clot by manipulating the elongatedmember; using at least one of the first actuation mechanism or thesecond actuation mechanism, expanding the second expandable member;using at least one of the first actuation mechanism or the secondactuation mechanism, expanding the first expandable member; using thethird actuation mechanism, axially moving the first expandable membertoward an opening in the lumen; using at least one of the firstactuation mechanism or the second actuation mechanism, compressing thefirst expandable member; using at least one of the first actuationmechanism or the second actuation mechanism, compressing the secondexpandable member; pulling the first expandable member and the secondexpandable member into the lumen; and removing the catheter from thepatient.

Optionally, the third actuation mechanism is used to axially move thefirst expandable member back and forth along said length.

Optionally, the third actuation mechanism is used to axially move thefirst expandable member toward an opening in the lumen and subsequentlyapplying suction to said lumen.

Optionally, the clot removal method further comprises applying suctionto the lumen.

Optionally, the first expandable member is configured to be moveablerelative to the second expandable member while the second expandablemember remains stationary.

Optionally, the second expandable member is configured to be moveablerelative to the first expandable member while the first expandablemember remains stationary.

Optionally, the first expandable member is configured to mechanicallyexpand or contract without affecting a size, dimension or shape of thesecond expandable member.

Optionally, the second expandable member is configured to mechanicallyexpand or contract without affecting a size, dimension or shape of thefirst expandable member.

In some embodiments, the present specification discloses a device forremoving an occlusion from a lumen within a patient's body, comprising:a handle having a distal end, wherein the distal end is coupled to aproximal end of a tip portion through one or more telescoping tubes,wherein the handle includes at least one actuation mechanism; and anelement mounted at the tip portion, wherein the element is in a firststate, wherein the handle is configured to steer the tip portion throughthe lumen so that the element is positioned within the occlusion,wherein the at least one actuation mechanism is manipulated in a firstdirection to transition the element from the first state to a secondstate within the occlusion, and wherein the element in the second stateis imparted one or more fore and aft motions to dislodge and scrape theocclusion.

Optionally, the first state corresponds to the element being in acontracted configuration and the second state corresponds to the elementbeing in an expanded configuration.

Optionally, the at least one actuation mechanism includes first andsecond knobs, wherein the first knob is manipulated to transition theelement from the first state to the second state, and wherein the secondknob is manipulated to impart the one or more fore and aft motions tothe element relative to the tip portion.

Optionally, the handle is moved fore and aft to cause the tip portionand therefore the element to be moved fore and aft.

Optionally, the at least one actuation mechanism includes a knob that ismanipulated to transition the element from the first state to the secondstate.

Optionally, the device further comprises a delivery catheter and anaspiration catheter, wherein the tip portion is positioned within thedelivery catheter and the delivery catheter is positioned within theaspiration catheter, and wherein a negative pressure is applied at aproximal end of the aspiration catheter to aspirate the dislodged andscraped occlusion.

Optionally, the at least one actuation mechanism is manipulated in asecond direction opposite to the first direction to transition theelement from the second state to the first state, and wherein the handleis used to retract the element in the first state from the lumen.

Optionally, the element has proximal, distal and center portions,wherein the proximal portion is shaped as a first funnel having a firstneck directed proximally along a longitudinal axis of the tip portionand the distal portion is shaped as a second funnel having a second neckdirected distally along the longitudinal axis, wherein respective cupedges of the first and second funnels are attached across a central axisto form the center portion, said central axis lying approximatelyorthogonal to the longitudinal axis.

Optionally, the element has a three dimensional geometric shape in thesecond state, and wherein the three dimensional geometric shape is oneor a combination of spherical, elliptical, conical, polygonal,cylindrical, stent, chalice cup, umbrella, concave, convex, half-sphere,sphere, windsock, dumbbell, star, polygon, or lever shapes.

In some embodiments, the present specification discloses a method ofusing a device to remove an occlusion from a lumen within a patient'sbody, wherein the device comprises a handle coupled to a proximal end ofa tip portion through one or more telescoping tubes, and an elementmounted on the tip portion, and wherein the element is in a first state,the method comprising: positioning the tip portion through a deliverycatheter; positioning the delivery catheter through an aspirationcatheter; steering, using the handle, the tip portion through the lumenso that the element is positioned within the occlusion; transitioning,by manipulating at least one actuation mechanism on the handle in afirst direction, the element from the first state to a second state; andimparting one or more fore and aft motions to the element in order todislodge and scrape the occlusion.

Optionally, the first state corresponds to the element being in acontracted configuration and the second state corresponds to the elementbeing in an expanded configuration.

Optionally, the at least one actuation mechanism includes first andsecond knobs, wherein the first knob is manipulated to transition theelement from the first state to the second state, and wherein the secondknob is manipulated to impart the one or more fore and aft motions tothe element relative to the tip portion.

Optionally, the handle is moved fore and aft to cause the tip portionand therefore the element to be moved fore and aft.

Optionally, the at least one actuation mechanism includes a knob that ismanipulated to transition the element from the first state to the secondstate.

Optionally, the method further comprises applying a negative pressure ata proximal end of the aspiration catheter to aspirate the dislodged andscraped occlusion.

Optionally, the method further comprises: transitioning, by manipulatingthe at least one actuation mechanism on the handle in a second directionopposite to the first direction, the element from the second state tothe first state; and retracting, using the handle, the element in thefirst state from the lumen.

Optionally, the element has proximal, distal and center portions,wherein the proximal portion is shaped as a first funnel having a firstneck directed proximally along a longitudinal axis of the tip portionand the distal portion is shaped as a second funnel having a second neckdirected distally along the longitudinal axis, wherein respective cupedges of the first and second funnels are attached across a central axisto form the center portion, said central axis lying approximatelyorthogonal to the longitudinal axis.

Optionally, the element has a three dimensional geometric shape in thesecond state, and wherein the three dimensional geometric shape is oneor a combination of spherical, elliptical, conical, polygonal,cylindrical, stent, chalice cup, umbrella, concave, convex, half-sphere,sphere, windsock, dumbbell, star, polygon, or lever shapes.

In some embodiments, the present specification discloses a device forremoving clot from a lumen within a patient's body, comprising: a handlehaving a distal end, wherein the distal end is coupled to a proximal endof a tip portion through one or more telescoping tubes, wherein thehandle includes at least one actuation mechanism; and an element mountedat the tip portion, wherein the element is in a first state, wherein thehandle is configured to steer the tip portion through the lumen so thatthe element is positioned within the clot, wherein the at least oneactuation mechanism is manipulated in a first direction to transitionthe element from the first state to a second state and from the secondstate to a third state within the clot, and wherein the element in thesecond state and/or the third state is imparted one or more fore and aftmotions to dislodge and scrape the clot.

Optionally, the second state corresponds to a first radial force that afirst size of the element applies to the clot and the third statecorresponds to a second radial force that a second size of the elementapplies to the clot, and wherein the second radial force is differentfrom the first radial force.

Optionally, each of the first and second radial force is in a range of 2Newtons to 20 Newtons.

In some embodiments, the present specification discloses a method ofusing a device to remove an occlusion from a lumen within a patient'sbody, wherein the device comprises a handle coupled to a proximal end ofan elongated member through a plurality of telescoping tubes, wherein adistal end of the elongated member has a tip portion mounted with aproximal element and a distal element, and wherein the proximal anddistal elements are in a first state, the method comprising: positioningthe tip portion through a delivery catheter; positioning the deliverycatheter through an aspiration catheter; steering, using the handle, thetip portion through the lumen so that the proximal and distal elementsare positioned within or beyond the occlusion; transitioning, bymanipulating a first physically manipulable interface on the handle in afirst direction, the distal element from the first state to a secondstate; transitioning, by manipulating a second physically manipulableinterface on the handle in a first direction, the proximal element fromthe first state to a second state; and moving, by manipulating a thirdphysically manipulable interface on the handle, the proximal elementfore and aft axially along the tip portion in order to dislodge,curettage and capture the occlusion between the proximal and distalelements; transitioning, by manipulating the first and second physicallymanipulable interfaces on the handle in a second direction opposite tothe first direction, the distal and proximal elements from the secondstate to the first state; and removing, using the handle, the proximalelement, the captured occlusion and the distal element from the lumen.

Optionally, the first state corresponds to each of the proximal anddistal elements being in a contracted configuration and the second statecorresponds to each of the proximal and distal elements being in anexpanded configuration.

Optionally, the method further comprises applying a negative pressure ata proximal end of the aspiration catheter to aspirate at least a portionof the dislodged occlusion prior to removing the proximal element, thecaptured occlusion and the distal element from the lumen.

Optionally, a length of the delivery catheter is in a range of 80 cm to160 cm.

Optionally, a length of the delivery catheter is 120 cm.

Optionally, the aspiration catheter is of 16 Fr and has a length in arange of 70 cm to 160 cm or the aspiration catheter is of 20 Fr and hasa length in a range of 60 cm to 150 cm or the aspiration catheter is of24 Fr and has a length in a range of 50 cm to 130 cm.

Optionally, the aspiration catheter is of 16 Fr and has a length of 112cm or the aspiration catheter is of 20 Fr and has a length 106 cm or theaspiration catheter is of 24 Fr and has a length of 90 cm.

Optionally, the aspiration catheter of 20 Fr has a distal end with a270° bend.

Optionally, the aspiration catheter of 24 Fr has a flexible distal end.

Optionally, in the second state the distal element has a first diameterand the proximal element has a second diameter, and wherein the firstdiameter is 16 mm and the second diameter is 20 mm or the first diameteris 5 mm and the second diameter is 20 mm.

Optionally, in the second state each of the proximal and distal elementshas an outer diameter ranging from 5 mm to 30 mm, preferably 10 mm to 25mm, and more preferably 10 mm to 20 mm.

Optionally, in the second state each of the proximal and distal elementshas a maximum outer diameter of 16 mm.

Optionally, the delivery catheter is of 9 Fr.

Optionally, a length of the delivery catheter is in a range of 40 cm to120 cm.

Optionally, a length of the delivery catheter is 80 cm.

Optionally, the aspiration catheter is of 16 Fr and has a length of in arange of 45 cm to 80 cm.

Optionally, the aspiration catheter is of 16 Fr and has a length of 65cm.

Optionally, in the second state the distal element has a first diameterand the proximal element has a second diameter, and wherein the firstdiameter is 16 mm and the second diameter is 14 mm.

Optionally, in the second state a diameter of the distal element is 16mm and a diameter of the proximal element is 8 mm.

Optionally, in the second state each of the proximal and distal elementshas an outer diameter ranging from 3 mm to 20 mm.

Optionally, in the second state the proximal element has a maximum outerdiameter of 16 mm and the distal element has a maximum outer diameter of20 mm.

Optionally, a distal end of the handle includes a fourth physicallymanipulable interface which can be manipulated to increase or decrease alength of the delivery catheter.

In some embodiments, the present specification discloses a method ofusing a device to remove an occlusion from a lumen within a patient'sbody, wherein the device comprises a handle coupled to a proximal end ofan elongated member through at least one telescoping tube, wherein adistal end of the elongated member has a tip portion mounted with aproximal element and a distal element, and wherein the proximal anddistal elements are in a first state, the method comprising: positioningthe tip portion through a delivery catheter; positioning the deliverycatheter through an aspiration catheter; steering, using the handle, thetip portion through the lumen so that the proximal and distal elementsare positioned within or beyond the occlusion; simultaneouslytransitioning, by manipulating a first physically manipulable interfaceon the handle in a first direction, the proximal and distal elementsfrom the first state to a second state; and moving the proximal anddistal elements fore and aft in order to dislodge and curettage theocclusion; applying a negative pressure at a proximal end of theaspiration catheter to aspirate at least a portion of the dislodgedocclusion; simultaneously transitioning, by manipulating the firstphysically manipulable interface on the handle in a second directionopposite to the first direction, the distal and proximal elements fromthe second state to the first state; and removing, using the handle, theproximal and distal elements from the lumen.

Optionally, the first state corresponds to each of the proximal anddistal elements being in a contracted configuration and the second statecorresponds to each of the proximal and distal elements being in anexpanded configuration.

Optionally, the proximal and distal elements are moved fore and aftusing the handle.

Optionally, the proximal and distal elements are moved fore and aft bymanipulating a second physically manipulable interface on the handle.

Optionally, a distance between the proximal and distal elements is fixedand ranges from 2 cm to 3 cm.

Optionally, in the second state each of the proximal and distal elementsopens incrementally to one of 20 different sizes, and wherein each ofthe 20 different sizes is capable of withstanding a same appliedpressure in the range of 0 to 25 Newton.

Optionally, the tip portion is guided through the lumen using aguidewire, and wherein the guidewire has a diameter of 0.018 mm.

Optionally, the aspiration catheter is of 7 to 8 Fr and has a length of135 cm.

Optionally, the elongated member is of 5 Fr and has a length of 145 cm.

The aforementioned and other embodiments of the present specificationshall be described in greater depth in the drawings and detaileddescription provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of systems,methods, and embodiments of various other aspects of the disclosure. Anyperson with ordinary skills in the art will appreciate that theillustrated element boundaries (e.g. boxes, groups of boxes, or othershapes) in the figures represent one example of the boundaries. It maybe that in some examples one element may be designed as multipleelements or that multiple elements may be designed as one element. Insome examples, an element shown as an internal component of one elementmay be implemented as an external component in another and vice versa.Furthermore, elements may not be drawn to scale. Non-limiting andnon-exhaustive descriptions are described with reference to thefollowing drawings. The components in the figures are not necessarily toscale, emphasis instead being placed upon illustrating principles.

FIG. 1 illustrates a deployment stage of an embodiment of the retrievaldevice, showing the proximal and distal bodies deployed on a deliverywire;

FIG. 2 illustrates the pre-deployment stage of the proximal and distalbodies, where the proximal and distal bodies are restrained orunexpanded;

FIG. 3 illustrates the expanded or released position of the proximal anddistal bodies from the delivery catheter;

FIG. 4 illustrates advancing the proximal body of the retrieval deviceaxially along the delivery wire to trap and compress a thrombus;

FIG. 5 illustrates the removal of a thrombus using the deployed proximaland distal bodies of an embodiment of the retrieval device;

FIG. 6 illustrates a deployment stage of an embodiment of the retrievaldevice, further showing a thrombus lodged in an artery;

FIG. 7 illustrates a deployment stage of an embodiment of the retrievaldevice, further showing a guide catheter;

FIG. 8 illustrates the guide catheter of FIG. 7 with balloon inflatedthus arresting anterograde blood flow through vessels;

FIG. 9 illustrates a delivery catheter positioned proximal to thethrombus with the delivery wire across the thrombus;

FIG. 10 illustrates a delivery catheter advanced over the delivery wireand across the thrombus;

FIG. 11 illustrates the retrieval device advanced through the deliverycatheter and positioned, with the bodies still restrained, proximal anddistal to the thrombus;

FIG. 12 illustrates the delivery catheter withdrawn proximally thusdeploying the proximal and distal mesh bodies proximal and distal to thethrombus;

FIG. 13 illustrates the proximal body released from its engagement withthe delivery wire and advanced axially along the delivery wire byadvancing the delivery catheter to trap and compress the thrombusbetween the proximal and distal bodies;

FIG. 14 illustrates the delivery catheter with the bodies and compressedthrombus being removed as a single unit while suction is applied to theguide catheters;

FIG. 15 illustrates an embodiment having an active segment having asection spanning the length of a thrombus, and a delivery segmentcontaining incorporation structure that is suture material between theproximal and distal bodies;

FIG. 16 illustrates an active segment having a section spanning thelength of a thrombus, and a delivery segment containing incorporationstructure that is collapsible sinusoidal wire material between theproximal and distal bodies;

FIG. 17A illustrates the retrieval device with a single tetherarrangement attached to the proximal body;

FIG. 17B illustrates the retrieval device with a double tetherarrangement attached to the proximal body;

FIG. 18 illustrates a deployment stage of the retrieval device, showingthe placement of a temporary balloon occlusion guide catheter intocommon carotid artery;

FIG. 19 illustrates an advancing access catheter into a vessel;

FIG. 20 illustrates advancing the delivery catheter and delivery wire tothe origin of an occlusion;

FIG. 21 illustrates temporary inflation of a balloon on a guide catheterto arrest anterograde flow;

FIG. 22 illustrates advancing the delivery wire, with the retrievaldevice loaded thereon, and delivery catheter across the thrombus andpositioning the tip of the delivery catheter distal to the thrombus;

FIG. 23 illustrates deploying the bodies of the retrieval device andadvancing the bodies device through the delivery catheter and deployingthe bodies distal to the thrombus;

FIG. 24 illustrates the proximal and distal bodies drawn proximally tothe thrombus and opening to a larger diameter when transitioning from M1to M2 and in the process of being withdrawn proximally;

FIG. 25 illustrates the proximal body being moved proximally by thetether;

FIG. 26 illustrates withdrawing the thrombus towards the access cathetercontaining suction;

FIG. 27 illustrates removal of the thrombus using the access cathetercontaining suction;

FIG. 28A is a perspective view of a retrieval device, in accordance withan embodiment of the present specification;

FIG. 28B is an exploded view of a distal tip portion of the device shownin FIG. 28A;

FIG. 28C is a side elevation view of an exemplary proximal element ofthe device shown in FIG. 28A;

FIG. 28D is a front plan view of the proximal element shown in FIG. 28C,in an expanded state;

FIG. 28E is a side elevation view of an exemplary distal elementassembly of the device shown in FIG. 28A;

FIG. 28F is a front plan view of the distal element shown in FIG. 28E inan expanded state;

FIG. 28G is another perspective view of the retrieval device shown inFIG. 28A;

FIG. 28H represents first, second, third, and fourth views of theretrieval device of FIG. 28A being manipulated to maneuver a tipportion, in accordance with some embodiments of the presentspecification;

FIG. 28I is an illustration of an occlusion captured between andembedded in mesh lattices of proximal and distal elements of theretrieval device of FIG. 28A, in accordance with an embodiment of thepresent specification;

FIG. 28J is a perspective view of a retrieval device, in accordance withanother embodiment of the present specification;

FIG. 28K is a longitudinal cross-sectional view of a handle of aretrieval device, in accordance with another embodiment of the presentspecification;

FIG. 28L shows proximal and distal elements of the retrieval device ofFIG. 28A, in accordance with an embodiment of the present specification;

FIG. 28M shows first, second and third views of using a key to unlock ahandle of a retrieval device, in accordance with an embodiment of thepresent specification;

FIG. 29A is a perspective view of a retrieval device withcontracted/unexpanded distal and proximal elements, in accordance withan embodiment of the present specification;

FIG. 29B is a perspective view of the retrieval device of FIG. 29A withexpanded distal and proximal elements, in accordance with an embodimentof the present specification;

FIG. 29C is a perspective view of the retrieval device of FIG. 29A withflexible elements between the distal and proximal elements retracted toreduce the distance between the distal and proximal elements, inaccordance with an embodiment of the present specification;

FIG. 30A is a perspective view of a retrieval device, in accordance withan embodiment of the present specification;

FIG. 30B is a perspective view of an expanded handle portion of theretrieval device shown in FIG. 30A, in accordance with an embodiment ofthe present specification;

FIG. 30C is a perspective view of a compressed handle portion of theretrieval device shown in FIG. 30A, in accordance with an embodiment ofthe present specification;

FIG. 30D is an illustration of expanded proximal and distal elements ofthe retrieval device shown in FIG. 30A, in accordance with an embodimentof the present specification;

FIG. 30E is an illustration of collapsed/contracted proximal and distalelements of the retrieval device shown in FIG. 30A, in accordance withan embodiment of the present specification;

FIG. 30F is an illustration of an embodiment of the expanded handleportion of the retrieval device, in accordance with an embodiment of thepresent specification;

FIG. 30G is a perspective illustration of a compressed distance betweenthe proximal and distal elements as a result of expanding the handleportion shown in FIG. 30F, in accordance with an embodiment of thepresent specification;

FIG. 30H is an illustration of the handle portion shown in FIG. 30F in acompressed state causing the distance between the proximal and distalelements to expand, in accordance with an embodiment of the presentspecification;

FIG. 31A is a flowchart of a plurality of exemplary steps of treatingpulmonary embolism (PE) by using the retrieval device shown in FIGS.28A-G and 28J-28L, in accordance with an embodiment of the presentspecification;

FIG. 31B is a flowchart of a plurality of exemplary steps of treatingdeep vein thrombosis (DVT) by using the retrieval device shown in FIGS.28A-G and 28J-28L, in accordance with an embodiment of the presentspecification;

FIG. 32A illustrates a human pulmonary artery with a chronic blood cloton a left side of said artery;

FIG. 32B illustrates a retrieval device such as that shown in FIGS.28A-28G, inserted into the pulmonary artery shown in FIG. 30A;

FIG. 32C illustrates an expanded distal element holding the blood clot,which can be removed from the pulmonary artery by withdrawing theretrieval device;

FIG. 33A is a side elevation view of a tip portion of a retrieval devicewith a bag covering the tip portion, in accordance with some embodimentsof the present specification;

FIG. 33B is a side elevation view of a tip portion of FIG. 33A with thebag pulled away to uncover the tip portion, in accordance with someembodiments of the present specification;

FIG. 33C is a side elevation view of a tip portion of FIG. 33B with thebag pulled back to cover the tip portion, in accordance with someembodiments of the present specification;

FIG. 34A is a side elevation view of proximal and distal elements of atip portion in unexpanded states, in accordance with some embodiments ofthe present specification;

FIG. 34B is a side elevation view of proximal and distal elements of thetip portion of FIG. 34A in expanded states, in accordance with someembodiments of the present specification;

FIG. 35 is a side elevation view of proximal and distal elements of atip portion in unexpanded states and attached to a tether, in accordancewith some embodiments of the present specification;

FIG. 36A illustrates a linear tangential section of a left iliac veinthat has not been subjected to an experimental thrombectomy procedure;

FIG. 36B illustrates a linear tangential section of a right iliac veinafter an experimental thrombectomy procedure;

FIG. 37A shows a first stage in a procedure of removing a clot in anerve vessel using a retrieval device, in accordance with someembodiments of the present specification;

FIG. 37B shows a second stage in the procedure of removing the clot inthe nerve vessel using the retrieval device, in accordance with someembodiments of the present specification;

FIG. 37C shows a third stage in the procedure of removing the clot inthe nerve vessel using the retrieval device, in accordance with someembodiments of the present specification;

FIG. 37D shows a fourth stage in the procedure of removing the clot inthe nerve vessel using the retrieval device, in accordance with someembodiments of the present specification;

FIG. 37E shows a fifth stage in the procedure of removing the clot inthe nerve vessel using the retrieval device, in accordance with someembodiments of the present specification;

FIG. 37F shows a sixth stage in the procedure of removing the clot inthe nerve vessel using the retrieval device, in accordance with someembodiments of the present specification;

FIG. 38 is a flowchart of a plurality of exemplary steps of retrievingan occlusion by using the retrieval device of FIGS. 37A through 37F, inaccordance with some embodiments of the present specification;

FIG. 39A shows a linear continuous flow model representative of a bloodvessel for performing experimental thrombectomy using a retrievaldevice, in accordance with some embodiments of the presentspecification;

FIG. 39B shows a plurality of exemplary tubes with artificialthrombus/clot, in accordance with some embodiments of the presentspecification;

FIG. 40A shows first, second and third views illustrating deploymentcapability of a retrieval device of the present specification withrespect to conventional, prior art devices;

FIG. 40B shows first, second and third views of the first conventionaldevice shown in FIG. 40A being sequentially retracted from a hot dog;

FIG. 40C shows first, second and third views illustrating a comparisonof thrombectomy capabilities of the conventional devices and theretrieval device of the present specification;

FIG. 41A illustrates a retrieval device having a single element ormember, in accordance with some embodiments of the presentspecification;

FIG. 41B is a side elevation view of an exemplary element of the deviceshown in FIG. 41A, in accordance with some embodiments of the presentspecification;

FIG. 41C is a front plan view of the element shown in FIG. 41B, in anexpanded state, in accordance with some embodiments of the presentspecification;

FIG. 41D is another perspective view of the retrieval device shown inFIG. 41A, in accordance with some embodiments of the presentspecification;

FIG. 42 is a flowchart of a plurality of exemplary steps of a method oftreating peripheral arterial disease (PAD) by using the retrieval deviceof FIG. 41A, in accordance with an embodiment of the presentspecification;

FIG. 43 is a flowchart of a plurality of exemplary steps of a method ofusing a retrieval device configured to remove an occlusion fromperipheral arterial vessels (and therefore treat peripheral arterialdisease), in accordance with an embodiment of the present specification;

FIG. 44 is a flowchart of a plurality of exemplary steps of removinggallstones by using a retrieval device, in accordance with an embodimentof the present specification; and

FIG. 45 is a flowchart of a plurality of exemplary steps of removingkidney stones by using a retrieval device, in accordance with anembodiment of the present specification.

DETAILED DESCRIPTION

In various embodiments, the retrieval devices of the presentspecification may be a catheter-delivered tool used to remove a foreignbody, such as a thrombus or clot, from an artery, vein, nerve, duct, orother interior physical space. The retrieval device may beinterchangeably referred to herein as “the device” or a “removaldevice”, the “removal” or “retrieval” of the foregoing may be modifiedby a variety of terms such as “thrombus,” “occlusion,” “foreign body,”etc. The retrieval device may be used as a foreign body retriever and asa thrombectomy device in the arterial, venous and neural systems. Thedevice may be used in the vascular system and in non-vascular structuressuch as ureters, ducts, airways, and any other accessible space thatcontains a material (biologic or foreign) that necessitates removal orretrieval.

In various embodiments, the retrieval devices of the presentspecification are configured to be used in: all venous structuresincluding dural venous sinuses, coronary arteries, cardiac chambers, allarteries, all ducts, ureters, urethra and fistulas.

The present specification is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

In the description and claims of the application, each of the words“comprise”, “include”, “have”, “contain”, and forms thereof, are notnecessarily limited to members in a list with which the words may beassociated. Thus, they are intended to be equivalent in meaning and beopen-ended in that an item or items following any one of these words isnot meant to be an exhaustive listing of such item or items, or meant tobe limited to only the listed item or items. It should be noted hereinthat any feature or component described in association with a specificembodiment may be used and implemented with any other embodiment unlessclearly indicated otherwise.

It must also be noted that as used herein and in the appended claims,the singular forms “a,” “an,” and “the” include plural references unlessthe context dictates otherwise. Although any systems and methods similaror equivalent to those described herein can be used in the practice ortesting of embodiments of the present disclosure, the preferred, systemsand methods are now described.

The term “clot”, “occlusion”, “blockage”, or “thrombus” shall each beused to refer to material in a patient's veins or arteries that isblocking the flow of blood or material in any of a patient's anatomythat is blocking the flow of any fluid, such as urine.

It should be appreciated that each of the embodiments disclosed hereinmay be used in one or more of the following medical procedures: a)septal heart repairs in which a catheter is manipulated to the patient'sheart in order to permanently place two connected patches in a hole tocover both the left and right atrial sides, b) pulmonary embolisms inwhich a catheter is manipulated proximate a blood clot that is lodged inan artery in the lung thereby blocking blood flow to part of the lung,c) deep vein thrombosis in which a catheter is manipulated proximate ablood clot that is lodged in a vein, often in the patient's legs,thereby blocking blood flow, d) repairing fistulas, e) removing fistulathrombus, f) removing stones from the patient's gastrointestinal system,g) removing stones from the patient's genitourinary system, h) removingforeign bodies from any location in the patient's body, or i) filterthrombus removal.

FIG. 1 depicts the deployed retrieval device with a distal body 104,which in this embodiment is a body mounted to the delivery wire 100 suchthat it remains in a fixed position. Referring to all embodimentsdisclosed herein, it should be noted that prior to deployment of thedelivery wire 100, a guide wire may be used to position any element ofthe system disclosed herein, including a delivery catheter 202, guidecatheter 204, and delivery wire 100 into the preferred position within avessel or other interior. The “bodies” referred to herein may be a mesh,and they may be made of nitinol or other suitable expandablebiocompatible material. The mesh construct of the distal 104 andproximal 102 bodies may reduce the risk of distal embolization ofportions of a clot since the mesh construct may capture embolic materialwithin its interstices. The distal body 104 may, in embodiments, havedifferently-sized mesh or may comprise a selectively permeable material,or it may be non-permeable. A proximal body 102 is also shown. Theproximal body 102 is mounted to the delivery wire 100 and is temporarilyaffixed thereto such that it remains in a fixed position. The temporaryaffixed aspect referred to above is releasable such that upon releasethe proximal body 102 may move along the wire, which is referred toherein as “axial movement” along the wire, while remaining engaged tothe wire 100. This aspect is referred to as being in “releasableengagement” or being “releasably engaged” to the delivery wire 100. Suchreleasable engagement may be achieved, for example, by using breakableconnection 108, which in embodiments, may be an electrolytically or heatremovable/disconnectable connection or mechanical connection that can beselectively disconnected by the clinician. In the case of anelectrolytically or heat removable/disconnectable connection, forexample, the clinician may apply a current to the connection, (inembodiments via the wire which may be conductive) wherein the electricalcurrent breaks or melts the connection. The connection may include,without limitation, a breakable connection 108, linking a proximal body102 to the delivery wire 100, that may be eroded and/or disintegratedthrough the application of electrical current. The breakable connection108 may be preloaded onto the retrieval device in order to secure theproximal body 102 in a preferred location and/or configuration. Thebreakable connection may have a plurality of shapes and designs,including but not limited to a straight post extending from the deliverywire 100 to the proximal 102 or other body, a loop configuration of thebreakable connection passing through the material of the proximal 102 orother body, and/or a “nail” configuration in which a straight postextends from the delivery wire to the proximal 102 or other body,wherein the post has an enlarged end, or nail head, within the body thatmay be eroded by the application of electric current to release thebody. Embodiments of the present invention include a proximal 102 orother body that may be secured to the delivery wire 100 using more thanone breakable connection 108. In an example, a proximal body 102 may besecured with multiple breakable connections, each having a differentlength and a different release threshold, allowing the breakableconnections to be sequentially released. In embodiments, more than oneproximal body may be secured to the delivery wire 100 using a breakableconnection 108. Melting of a breakable connection may be caused by theapplication of electrical current, fluid, and/or chemical compounds.Melting may occur in a physical member that is used to secure theproximal or distal body and/or may occur within an adhesive that bindsthe physical member to the proximal, and/or the delivery wire 100.Breakable connection techniques and methods, including but not limitedto those shown in U.S. Pat. Nos. 5,683,451, 5,855,578, 6,245,076,8,273,116. and U.S. patent applications 20070100414A1, 20090062726A1,and 20100268251A1, may be used to release a proximal body and/or distalbody, as described herein. In the case of a mechanically breakableconnection, the breakable connection 108 may be made of a suture, brace,thread or other material that is able to be broken upon application offorce to the breakable connection 108. In embodiments, the distal motionof a catheter, such as the delivery catheter, with a force above thethreshold holding force of the breakable connection 108 may cause theconnection 108 to break or release, thus allowing the body 102 to movealong the wire in the manners described herein. The “bodies” referred toherein may be of various geometric shapes including a disc or sphere. Inembodiments, the distal body 104 and/or proximal body 102 may be aninflatable device, including but not limited to an inflatable balloon.In embodiments, a retrieval device, as described herein, may include adistal body 104 and a proximal body 102 made of differing materials, forexample a proximal body 102 may be an inflatable balloon and a distalbody 104, on the same retrieval device, may be made of a mesh material.In embodiments, by adjusting the manufactured radial force, bodydiameter, and strength of the bodies, foreign body extraction, asdescribed herein, may also be used for the removal of stones, pulmonaryemboli, or some other type of obstruction. In embodiments, a proximaland/or distal body may have variable radial force, or stiffness acrosssub-regions of the body itself. For example, the upper hemisphere of aspherical body may have a difference radial force characteristic thanthe lower hemisphere of the body. In embodiments, the proximal anddistal bodies may be substantially the same. In other embodiments, theproximal and distal bodies may be heterogeneous, having differentcompositions and characteristics including, without limitation, shape,size (e.g., thickness, diameter), configuration, pore size (e.g., meshpore size), coating, or some other differing characteristic. Inembodiments, the proximal and/or distal bodies may have anti-platelet,or some other type of, coatings to reduce adhesion and provide a lessthrombogenic environment during clinical application. The proximaland/or distal bodies, and any material (e.g., wires) between thesebodies, may be coated with control release agents including, but notlimited to, thrombolytic agents.

The “delivery wire” 100 referred to herein may be a wire or a hypo tube.The delivery wire 100 may not require a coaxial system of catheters asdisclosed herein in embodiments.

The “delivery catheter” 202 referred to herein may be referred to as amicrocatheter, and may form a plurality of shape configurations based onthe clinical application in which it is used, for example, which type ofvessel the delivery catheter is used within, the vessel size, the vesselshape, or some other application characteristic. In embodiments, adelivery wire and/or hypo tube may be used within a microcatheter. Forpurposes of this disclosure, the microcatheter 202 is commonly called a“delivery catheter”, although it should be understood that the terms canbe used interchangeably.

Referring to FIG. 2, prior to deployment of the distal 208 and proximal210 bodies (which are shown as being restrained or in their unexpandedform and thus having different reference numerals from the FIGS. 1, and3-5) the delivery catheter 202 surrounds the delivery wire and restrainsboth bodies 208, 210. In embodiments, a guide catheter 204 is navigatedinto place, in embodiments, over a guide wire, said guide wire in someembodiments being removed. The delivery catheter 202 may be passedthrough an object, such as a thrombus or clot 212, the bodies 208, 210may be released from the delivery catheter 202 either by retracting thedelivery catheter 202 or advancing the wire 100, such that expandablebodies are no longer restrained by the delivery catheter 202. The distalbody 104 remains fixed to the delivery wire 100, but the proximal body102 (once released from its releasable engagement) can freely move alongits axis and longitudinally along the delivery wire 100 when pushed bythe delivery catheter 202. Also, the delivery wire 100 “pushing” thebody (210 or 102 once expanded) must be understood as relative pushing.That is, the retraction of the delivery wire 100 while the deliverycatheter 202 is kept in place may serve to move the proximal body 102axially along the wire. The term “pushing” as is used herein will referto both forms of movement mentioned above. Once the proximal and distalbodies are positioned adjacent to both sides of the clot (which has beenreferred to herein as “surrounded” or “surrounding” the clot) bymovement of the proximal body 102, the clot may be removed by retrievingthe device from the cavity and pulling the clot free. The terms “clot,”“thrombus,” “occlusion,” “occlusive substance” and “foreign body” may beused interchangeably herein.

In embodiments, the freedom of movement of the proximal body 102 on thedelivery wire 100 axially may allow for the compression of the occlusivesubstance and obviate the need for pre-measuring or estimating therequired distance between the distal and proximal bodies prior toentering the vessel 200; sizing may take place in situ within the vessel200 upon the interventionist encountering it.

In embodiments of the present disclosure, the retrieval device mayconsist of a distal body 104 and a proximal body 102, each of which inembodiments may be collapsible geometric forms. Although the distal andproximal bodies are presented for diagrammatic purposes as spherical,the distal and proximal bodies may also be other geometric forms such asa disc, cone, oblong-shaped form, etc. As mentioned above, the distaland proximal bodies may be a mesh in structure. The mesh cell size maybe manufactured to have different sizes based on factors such as theexpected properties of the target foreign matter to be removed, such asthe density of the matter. The distal body 104 is mounted on a deliverywire 100 such that it remains fixed. In embodiments, the mounting of theproximal body 102 occurs by running the wire through one of the meshopening. In other embodiments, the proximal body 102 itself may have anopening through which the wire may pass. In either case of mounting theproximal body 102, the body is able to slide along the wire in an axialdirection along the wire. This may be referred to herein as “slidablymounted”. In some embodiments, the distal body 104 may be slidablymounted in the way described above. As described above, the proximalbody may be detachable (thus releasably engaged) using mechanical,electrolytic or some other type of control release format. Inembodiments, the proximal body 102 will be slidable along the wire onereleased while the distal body 104 remains fixed. In other embodiments,both the proximal and distal bodies may be releasably engaged and thusslidable or movable along the delivery wire 100. Still in otherembodiments, the proximal body 102 may be comprised of multiple bodies,and the distal body 104 may be comprised of multiple bodies. The meshmaterial of the distal and proximal bodies may have advantages overother material types, including but not limited to inflatable balloons.Inflatable material may be susceptible to rupture, such as that causedby over inflation. The clinical setting may also be associated withcomplications related to the use of inflatable balloons within a lumen.For example, a calcified thrombus may increase the risk of balloonrupture. In another example, if an occlusion itself includes metallicmaterial, this may also increase the risk of rupture or othermalfunction of an inflatable balloon. Rupture of a balloon may in turnincrease the risk of an air embolus forming within the vessel or cavityof intervention. In embodiments, the mesh material of the distal andproximal bodies may allow for the bodies to expand upon release to thediameter and configuration of the cavity in which it is placed, such asa vessel 200 in which a thrombus 212 is located. Such meshes may be madeof a shape memory substance such as nitinol. For example, a body made ofnitinol mesh may expand to a first dimension outside of a vessel 200 orcatheter, but may be designed to expand to a continuum of smallerdimensions than the first dimensions corresponding to different lumensizes. In this way the bodies may fit the unique variations in diameterfound in a lumen at the point of release and/or point of placement nearan occlusion, such as a thrombus. Mesh material may also allow forimproved distal flow during an intervention. The irregularity and/ortexture of the expanded mesh material may facilitate the mesh materialbecoming entangled or otherwise incorporated with a clot or occlusivesubstance, thereby increasing adhesion of the distal and/or proximalbody with the occlusion and facilitating its removal.

In embodiments, when the proximal body 102 is released, it may be freeto move/slide on its axis along the delivery wire 100 in a longitudinaland/or rotational fashion. Referring to FIG. 3 when the distal body 104is placed distal to the target thrombus 212 for retrieval and theproximal body 102 is placed proximal to the thrombus 212, the distal andproximal bodies will straddle and contain the thrombus 212 intended forremoval from the vessel. The proximal body 102 may now be advanced inthe direction of the thrombus 212 in a variety of mechanical fashions.As shown in FIG. 4, a coaxially placed microcatheter, also referred toherein as a “delivery catheter” 202, may be pushed forward (once theproximal body is released) and used to physically advance the proximalbody 102 to ultimately capture and compress the thrombus 212.Alternatively, the delivery catheter 202 may be used to hold theproximal body 102 in a fixed position while the delivery wire 100 iswithdrawn thus moving the fixed distal body 104 towards the proximalbody 102 and ultimately capturing and compressing the thrombus 212. Asshown in FIG. 5, once the thrombus 212 is captured/compressed betweenthe distal body 104 and the proximal body 102, the entire retrievaldevice may be removed from the patient via withdrawal of the deliverywire 100 by, for example, withdrawing the proximal and distal bodieswith the compressed material back to, and against, the delivery catheterand then removing the delivery catheter, bodies and compressed materialthrough the guide catheter. Once this is removed, the guide catheter maybe withdrawn from the vessel.

In embodiments of the present disclosure, the retrieval device may beemployed as part of the removal of an occlusive object or substance froma human vessel, such as performing arterial thrombectomy. This proceduremay include the following generalized steps. FIG. 6 shows an occlusionin the proximal left internal carotid artery (ICA). FIG. 7 shows anembodiment having a guide catheter 700 with a balloon 702 (“ballooncatheter”). In embodiments, suction may be applied through the guidecatheter 700, in effect utilizing the guide catheter 700 as a suctioncatheter, as a given intervention may require. The balloon 702 isdeflated an inserted into the ICA over a guide wire 704. FIG. 8 shows adelivery catheter 202 advanced through the balloon catheter over theguide wire 704, which has been advanced. FIG. 9 shows a guide wire 704being advanced through and distal to the occlusion 212. FIG. 10 showsthe delivery catheter 202 being advanced through and distal to theocclusion over the guide wire 704. The guide wire 704 is then removed(not shown) and FIG. 11 shows the retrieval device (delivery with distal208 and proximal 210 bodies mounted on a delivery wire 100 as describedherein) inserted into the delivery catheter 202 and still retrained(unexpanded) in the delivery catheter 202. In FIG. 12 the deliverycatheter 202 has been withdrawn (moved relative to the delivery wire100) such that the proximal 102 and distal 100 bodies expand on eitherside of the occlusion 212. The proximal body 102 having been released isthen advanced distally (shown in FIG. 13) by force of the deliverycatheter 202 (either by pushing the delivery catheter 202 or by pullingthe delivery wire 100 while restraining the position delivery catheter202). FIG. 14 shows withdrawal of the retrieval device from the ICA,balloon 702 still inflated to arrest anterograde flow.

The retrieval device may remove both organized and unorganized thrombisince, in embodiments, the bodies of the retrieval device do not need tobe incorporated into the thrombus 212 to affect its removal. Theretrieval device may also remove calcified, atherosclerotic materialsince, in embodiments, the bodies of the retrieval device do not need tobe incorporated into the material to affect its removal. The retrievaldevice may be used centrally and peripherally by selecting theappropriate diameter and characteristics of the bodies, such asappropriate radial force or stiffness, appropriate shape, whether thebodies are substantially identical or homogenous, mesh opening size inthe bodies, and the like.

The methods, system and apparatus, as described herein, may have aplurality of sizes loaded within a common catheter, and a clinician mayself-load, for example, different and/or additional proximal bodies, asdescribed herein, rather than having to fully replace a deployedcatheter for a second catheter-based device and system. This may reducemanufacturing costs and improve intervention efficiency.

FIGS. 15 and 16 show embodiments having a structure to incorporate intothe thrombus 212, referred to herein as an “incorporation structure”. Insome embodiments, the incorporation structure is part of the deliverywire 100, in others it is separate. Referring to FIGS. 15 and 16, thedelivery wire 100 (which in all embodiments disclosed herein may be ahypo tube) comprises a segment having characteristics different fromthat of the main segment of the delivery wire 100, or a structuremounted to the delivery wire 100 that may expand. In the case where theincorporation structure is part of the delivery wire 100, the segmentwill be referred to herein as the “active segment” while the remainderof wire will be referred to as the “delivery segment”. The activesegment is the segment having a section intended to span the length ofthe thrombus 212. In embodiments, the active segment comprises across-sectional shape that differs from the delivery segment. Inembodiments, the delivery segment contains a suture material 1500between the proximal 102 and distal 100 bodies. The suture material 1500gathers and moves along the delivery wire 100 as the proximal body 102is advanced. Once the proximal body 102 is in position, the suturematerial 1500 will be gathered in the area between the two bodies whichwill enhance incorporation characteristics of the active area. Note thatthe active area in the above example is the area between the two bodies,which in this case, has suture material 1500 gathered therebetween. Asmentioned above, in embodiments the incorporation structure can be anadditional expandable structure between the proximal 102 and distal 100bodies that expands and incorporates into the thrombus 212. Theincorporation structure may comprise other mechanisms to enhancethrombus-incorporation, such as flanges, hooks, sutures, sinusoidal wire1600, or some other material configuration.

In embodiments, the delivery wire 100 may include a distal body 104 thatmay be affixed, mounted, adhered or otherwise connected to a deliverywire 100 or hypo tube as described herein. Prior to deployment, such asa thrombectomy, the distal body 104 may be affixed, mounted, adhered orotherwise connected to the delivery wire 100 or hypo tube in a collapsedor compressed state. Compression of the distal body 104 may be providedby the delivery catheter 202, and/or multiple catheters which surroundthe distal body 104 and delivery wire 100 (as described herein). Oncethe delivery catheter 202 is inserted through an object, such as athrombus, the distal body 104 may be released from inside the deliverycatheter 202 as described herein, thus expanding. Following removal ofthe delivery catheter 202, suction may be applied to the thrombus orother blockage. (It is to be noted that a suction step, as describedherein, may be applied to any of the embodiments of this disclosure, andmay be applied through the guide catheter, access catheter, specializedsuction catheter, or some other type of catheter). In an example, theSeldinger technique may be initiated using a large bore suction catheterthat is advanced over the delivery wire 100 (or a guide wire) andpositioned proximal to the thrombus 212, with the distal body 104distally positioned to the thrombus. Suction may be applied to removeall or a portion of the thrombus. The positioning of the distal body104, on the distal side of the thrombus, may be used to retract thethrombus in the direction of the suction device, thereby increasing theeffectiveness of the suction device in removing the thrombus. The distalbody 104 may also provide distal protection from distal embolizationduring the suction device's placement and/or during the suctioningprocedure. Note that in the above example, a proximal body has not yetbeen included in the procedure. There are situations and thusembodiments where an optional proximal body 102 may be added to theprocedure, for example, by slidably mounting a proximal body 102 to thedelivery wire 100. As such, in embodiments the inclusion of a proximalbody 102 is optional.

In some clinical scenarios the suction procedure may result in only apartial removal of the thrombus 212 or other obstruction. In suchscenarios, mechanical removal of the thrombus 212, using a distal bodyand an added proximal body 102, may be advantageous and/or required.Following the application of suction within the guide catheter 700, aproximal body 102 may be added to the delivery wire 100, where thisproximal body 102 is proximal to the thrombus 212 or other obstruction.Once the proximal body 102 is placed on the delivery wire 100, it may beadvanced towards the distal end of the delivery wire 100 by advancingthe delivery wire 100. In another example, the proximal body 210, in arestrained position, may be advanced towards the distal end of thedelivery wire 100 using a hypo tube that is placed within the deliverycatheter 202 over the delivery wire. As the hypo tube is pushed towardsthe distal end of the delivery wire 100, the proximal body 210 may bemoved axially to a desired location. Once the proximal body 210 is inthe desired physical position, relative to the thrombus 212 or otherobstruction, the proximal body 210 may be released from inside thedelivery catheter 202 to form the expanded proximal body 102 in a manneralready described herein. The coaxially placed hypo tube may be pushedforwards and used to physically advance the proximal body 102 toultimately capture and compress the thrombus 212. Once the thrombus 212is captured/compressed between the distal body 104 and the proximal body102, the entire retrieval device may be removed from the body viacoaxially placed catheters/tubes thus permitting removal of the thrombus212 from its prior resting place within the vessel.

Referring to FIGS. 17A and 17B, the proximal body may be moved along thedelivery wire via application of force to a tether or multiple tethers.As shown in FIG. 17A, a single proximal tether 1700 may be attached tothe proximal body 102, the proximal body 102 being slidably mounted andin releasable engagement to a delivery wire (or hypo tube), as describedherein. The proximal tether 1700 may be pulled to move the proximal bodyback, proximally along the wire 100 after the proximal body 102 has beenreleased and positioned in the manner described herein. The proximaltether 1700 may run parallel and within the delivery catheter (notshown) or, as shown in FIG. 17A, the proximal tether 1700 may run withina hollowed-out portion of the delivery wire or hypo tube and emergethrough an opening 117A. The proximal end 1710 of the proximal tether1700 is accessible to the interventionist who can pull it to pull back,proximally to the proximal body 102 at least to the point adjacent tothe opening 117A.

FIG. 17B shows a two-tether embodiment. As with the embodiment shown inFIG. 17A, the tethers may run parallel and within the delivery catheter(not shown) or, as shown in FIG. 17B, the proximal tether 1700 anddistal tether 1702 may run within a hollowed-out portion of the deliverywire or hypo tube and emerge through openings 117A and 117B, where theproximal tether 1700 emerges from opening 117A and the distal tether1702 emerges from opening 117B. Movement of the proximal body via theproximal tether, in the proximal direction, is the same as mentionedabove. In this embodiment, the interventionist can pull the end of thedistal tether 1720 to move the proximal body 102 adjacent to the opening117B, which results in a distal movement of the proximal body 102without the need for distal movement via the delivery catheter asdescribed herein.

In addition to the steps of deployment mentioned above, the followingsteps may also or alternatively be followed for using the retrievaldevice in embodiments. FIG. 18 shows the common carotid artery (CCA)having an occlusion therein 212. A guide catheter 1800 having a flowarrest balloon 702 is inserted into the CCA (in embodiments over a guidewire). FIG. 18 shows the flow arrest balloon 702 as deflated. FIG. 19shows the advancement of an access catheter 1900 distally through theguide catheter 1800 (in embodiments over a guide wire (not shown)). FIG.20 shows the distal advancement of a delivery catheter 202 via a guidewire 704 to the origin of the inclusion (i.e., the base of the thrombus212). FIG. 21 shows the flow arrest balloon 702 being temporarilyinflated to arrest anterograde flow in the CCA as well as the deliverycatheter 202 being advanced distal to the occlusion 212 via the guidewire 704 and, in this case, in M1. The guide wire 704 is removed (notshown). The delivery wire 100 with restrained proximal 210 andrestrained distal 208 bodies thereon is inserted into and through thedelivery catheter 202 with the tip emerging the delivery catheter asshown in FIG. 22. In this example, the delivery wire 100 has within it aproximal tether 1700 and a distal tether 1702.

In FIG. 23, the proximal 102 and distal 104 bodies are deployed distallyto the occlusion 212, the deployment being in the manner describedherein. The delivery catheter 202 is withdrawn from patient to increaseopen luminal area in access catheter 1900, which allows for bettersuction when suction is applied to access catheter 1900. FIG. 23 alsoshows the proximal tether 1700 and the distal tether 1702, as describedherein, attached to the proximal body 102. FIG. 23 also shows thedeflation of flow arrest balloon 702 on the guide catheter 1800 to endflow arrest. Due to mesh construct of the proximal 102 and distal 104bodies which are now deployed, anterograde flow into vessels will bere-established with protection (established via the expanded proximal102 and distal 104 bodies) from distal embolization of occlusion whenflow is re-established. Suction may be applied to the access catheter1900 at this point. The proximal body 102 may be released from itsreleasable engagement 108 as described herein, while the distal body 104remains fixed to the wire.

With both the proximal 102 and distal 104 bodies providing protection(most commonly initially in an M2 branch for an M1 occlusion or coveringthe M1 bifurcation for an ICA terminus) an interventionist may slowlypull the delivery wire 100 in a proximal direction. This will draw bothbodies proximally (see FIGS. 23-25). The proximal 102 and distal 104bodies will open to a larger diameter when they transition from M1 to M2and in the process of being withdrawn proximally will begin thethrombectomy process (see FIG. 25).

Once the distal body 104 opens at the M1 bifurcation, both superior andinferior M2 protection has been established (see FIGS. 24 and 25). Usinga proximal tether 1700 and a distal tether 1702 that connect to theproximal body 102 and exit from the delivery wire 100 either via anopening in the outer surface or via the opening on the end of thedelivery wire 100 (see FIGS. 17A and 17B), the proximal body 102 can bemoved along the M1 and possibly ICA lumen back and forth (i.e.,proximally and distally axially along the delivery wire) by pulling theends of the tethers 1710, 1720 as described herein and as desired by theclinician to mobilize occlusion and loosen and draw it proximallytowards the suction device. If the initial placement of the proximalbody 102 is determined to be too far in the distal direction, theinterventionist may use the proximal tether 1700 that is attached to theproximal body 102 to pull the proximal body 102 back in the proximaldirection to place it farther from the distal end of the retrievaldevice. This allows the interventionist to adjust the proximal body'sposition along the wire 100 instead of only being able to advance theproximal body 102 in the distal direction. In an example, the proximalbody 102 may have a Kevlar tether that exits the delivery wire (or hypotube) 100 at an opening distance about 1-2 cm proximal to the proximalside of the proximal body 102 to which it is attached. Therefore, whilethe two bodies are initially adjacent to each other, the proximal body102, once electrolytic ally detached, can be withdrawn a distanceproximally along the delivery wire 100 axis 1-1.5 cm by pulling on theproximal tether 1700. (All distances herein may be adjusted according tothe need). It may be advanced by pushing it forward with the deliverycatheter 202 and/or a second, distal tether 1702 may exit the wire atopening 117B distally to the proximal body 102 which when pulled canpull the proximal body 102 distally back towards the distal body andadjacent to the opening 117B. Therefore, by pulling proximal tether 1700and/or the distal tether 1702 the proximal body 102 may slide backwardsand forwards along the delivery wire 100. In this example, thisconfiguration provides the proximal body 102 with 1-1.5 cm of traveldistance back and forth along the delivery wire 100. Despite anterogradeflow, the distal body 104 may provide protection against distalembolization of loosened/floating occlusion thus eliminating/reducingthe risk of distal embolization of this material (see FIG. 25).

Once the thrombus 212 has been removed/evacuated through the accesscatheter 1900, the proximal and distal bodies can be removed bywithdrawing them through the delivery catheter 202. This process willalso mechanically draw any thrombus 212 that sits on the tip of theaccess catheter 1900 (cleans the catheter tip) into the catheter 1900 sothat it does not embolize off the catheter tip and back into theintracranial circulation (see FIGS. 25-27).

In embodiments, the following steps may be followed for using theretrieval device, as described herein, for a foreign body (e.g., lostcoil or fractured filter) capture and extraction intervention, such asan aneurysm coil lodged at an M1 bifurcation (proximal and distal bodiesmay be sized according to vessel size where the foreign body islocated):

Guide catheter 1800 already in ICA from coiling procedure.

Advance a delivery catheter 202 distal to the foreign body.

Advance the retrieval device through the delivery catheter 202 (the“retrieval device”, again is the delivery wire 100 with the proximal anddistal bodies mounted thereon in a manner described in this disclosure).

When the distal body 104 reaches the end of the delivery catheter 202,the interventionist may optionally detach the releasable engagement ofproximal body 102 so it is free to move axially along the delivery wire100.

Pull the proximal tether 1700 and draw the proximal body 102 proximallyin the delivery catheter 202 so that there is a space, in someembodiments a 1 cm space, between the two non-deployed bodies which arestill constrained within the delivery catheter 202.

Slowly retract the delivery catheter 202 proximally. This will allow thedistal body 104 to open in the vessel 200 distal to the foreign body.

Holding the wire in place, continue drawing the delivery catheter 202proximally until the proximal body 102 is unsheathed. The proximal body102 will now be opened proximal to the foreign body/coil.

The foreign body is now trapped/isolated between the distal and proximalbodies.

While holding the distal body 104 in place by holding the delivery wire100, the proximal body 102 can now be approximated along the wire to thedistal body 104 by either using the tethers as described herein or bysimply pushing it forward with the delivery catheter 202 or drawing thedistal body 104 proximally.

The foreign body/coil is now trapped between the two bodies and can beremoved from the vessel 200. By pulling the entire system down to orinto the guide catheter 1800.

In another embodiment, the present specification describes a medicaldevice for retrieval and removal of at least one occlusion from apatient's blood vessel(s) and, in embodiments, bronchial pathways. Thedevice may also be used in the vascular system of a patient, and innon-vascular structures such as ureters, ducts, airways, and any otheraccessible space that contains a material (biologic or foreign) thatnecessitates removal or retrieval. In one embodiment, each of thedevices disclosed herein may be used to perform a procedure in order toresolve, treat, or address a deep vein thrombosis or a pulmonaryembolism or perform any type of thrombectomy.

FIG. 28A illustrates a retrieval device, in accordance with anembodiment of the present specification. FIG. 28B illustrates anexpanded view of a distal tip portion of the device shown in FIG. 28A.FIG. 28C illustrates a proximal element of the device shown in FIG. 28A.FIG. 28D illustrates a front/top view of the proximal element shown inFIG. 28C, in an expanded state. FIG. 28E illustrates a mechanicallyexpanded distal element of the device shown in FIG. 28A. FIG. 28Fillustrates a front/top view of the distal element shown in FIG. 28E inan expanded state. FIG. 28G illustrates another view of the retrievaldevice shown in FIG. 28A and FIG. 28J illustrates a retrieval device, inaccordance with another embodiment of the present specification.

Referring simultaneously to FIGS. 28A through 28G and FIG. 28J, device2800 comprises a first unit 2890 that includes a handle 2802 coupled toa proximal end of an elongated member 2805 having a plurality oftelescoping tubes, such as at least four telescoping tubes, wherein adistal end of the elongated member 2805 has a tip portion 2804. Thehandle 2802 is configured to steer the tip portion 2804 in proximity toan occlusion. The device 2800 further comprises a second unit 2892 thatincludes an aspiration catheter 2835 having a suction source such as,for example, a syringe 2837, a one-way valve 2839 and a port 2842 (FIG.28A), where the port 2842 is coupled to a proximal end 2844 of theaspiration catheter 2835. In one embodiment the one-way valve 2839 isconfigured to direct suction through the aspiration catheter 2835. Foruse during a procedure, the tip portion 2804 is placed into a deliverycatheter 2848 and thereafter the delivery catheter 2848 is inserted intothe aspiration catheter 2835, and follows through to port 2842, so thatat least the tip portion 2804 projects distally from a distal end 2846of the aspiration catheter 2835.

In some embodiments, as shown in FIG. 28J, instead of the port 2842 thedevice 2800 includes a hemostasis valve hub 2842 j. The valve hub 2842 jis defined by an enclosure 2805 j, a first opening 2810 j in a first endof the enclosure 2805 j, a second opening 2812 j in a second end of theenclosure 2805 j, and an actuator 2815 j extending upward out of theenclosure 2805 j. In embodiments, the proximal end 2844 of theaspiration catheter 2835 is coupled to the second opening 2812 j. Whenthe actuator 2815 j is depressed, the valve hub 2842 j is configured toreceive the elongated member 2805 through the first opening 2810 j andallow the elongated member 2805 to pass through the second opening 2812j and through the aspiration catheter 2835. When the actuator 2815 j isnot depressed, the valve hub 2842 j is configured to create a sealaround a surface of the elongated member 2805. In embodiments, thesuction source 2837 is coupled to a portion of the valve hub 2842 j andis in pressure communication with the aspiration catheter 2835.

In accordance with aspects of the present specification, the device 2800is configured to enable an operator to single-handedly operate/actuatethe handle portion 2802 (using first, second and third physicallymanipulable interfaces such as, for example, knobs, sliders, buttons orother actuation mechanisms 2814, 2818 and 2820) in order to mechanicallyexpand, contract, or move a proximal member 2806 and/or a distal member2807, as further discussed below. In one embodiment, a first slider,knob, button, or other actuation mechanism 2814 is configured tomechanically expand or mechanically contract the proximal member 2806, asecond slider, knob, button, or other actuation mechanism 2818 isconfigured to mechanically expand or mechanically contract the distalmember 2807, and a third slider, knob, button, or other actuationmechanism 2820 is configured to axially move the proximal member 2806relative to the distal member 2807, to axially move the proximal member2806 while maintaining the distal member 2807 stationary, or to axiallymove the distal member 2807 while maintaining the proximal member 2806stationary.

It is preferred that the proximal and distal members 2806, 2807disclosed herein are not self-expandable or self-contractable but,rather, only expand or contract when a pressure is manually applied orreleased using the physically manipulable interfaces (such as, forexample, knobs, sliders, buttons or other actuation mechanisms)integrated into the handle 2802.

In one embodiment, as shown in FIG. 28A, the first slider, knob, button,or other actuation mechanism 2814, the second slider, knob, button, orother actuation mechanism 2818, and the third slider, knob, button, orother actuation mechanism 2820 are positioned in an arc around anexternal surface of the handle 2802 such that each of the first, second,and third actuation mechanisms are at the same location, or within 3inches, axially along the length of the handle. In another embodiment,as shown in FIG. 28J, the first slider, knob, button, or other actuationmechanism 2814, the second slider, knob, button, or other actuationmechanism 2818, and the third slider, knob, button, or other actuationmechanism 2820 are positioned on a flat external surface of the handle2802 such that each of the first, second, and third actuation mechanismsare positioned adjacent to each other. In some embodiments, as shown inFIG. 28J, a proximal end of the handle 2802 includes a first guidewireport 2820 j and a second flush port 2822 j. Also, in some embodiments,as shown in FIG. 28J, a distal end of the handle 2802 includes a fourthphysically manipulable interface such as, for example, a slider, knob,button, or other actuation mechanism 2811 j used to slidably advance orretract the delivery catheter 2848. The physically manipulable interface2811 j allows for a greater length of the delivery catheter 2848 to bepassed through the hemostasis valve hub 2842 j. In some embodiments,pressing the physically manipulable interface 2811 j allows the user tomove or slide the physically manipulable interface 2811 j towards oraway from the tip portion 2804 thereby increasing or decreasing thelength of the delivery catheter 2848 passing through the valve hub 2842j. Further, in some embodiments, as shown in FIG. 28J, the proximal end2844 of the aspiration catheter 2835 (or the distal end of the valve hub2842 j) includes a port 2813 j for injecting saline or a contrastingagent, when required.

In another embodiment, the handle comprises one or more actuationmechanisms to deliver medications and, in particular, can deliver tPA(tissue Plasminogen Activator) and/or activate an aspiration whileproviding distal embolic protection because of the stationary positionof the distal member. In one embodiment, a method of treatment wouldinclude infusing tPA into at least one lumen positioned within thecatheter. Preferably the infusion is performed at the outset of thepulmonary embolism or deep vein thrombosis treatment process, while theproximal and/or distal members are still housed within the catheter,thereby covering the unexpanded proximal and/or distal members in tPA.Alternatively, the infusion is performed at the outset of the pulmonaryembolism or deep vein thrombosis treatment process, while the proximaland/or distal members are still housed within the catheter, directedthrough the distal end of the catheter, and injected directly into theclot prior to inserting and expanding the proximal and/or distalmembers.

In another embodiment, the catheter and handle, in combination, areconfigured to deliver ultrasonic energy to a clot in order to acceleratelytic dispersion, drive medications deeper into the clot, speed thebreakdown of the clot, and/or degenerate or unwind the fibrin quicker.In one embodiment, the catheter comprises an ultrasonic core in parallelwith the elongated wire extending axially through the catheter lumen.The ultrasonic core is in electrical communication with a control unitpositioned external to the catheter. The proximal end of the handlewould preferably have one or more leads in electrical communication withthe ultrasonic core that would extend outward from the handle and beconfigured to connect to the control unit. During the pulmonary embolismor deep vein thrombosis treatment process, the ultrasonic energy wouldbe activated, using the control unit, at the beginning of the treatmentupon delivery of the medications, as described above.

In embodiments, an ultrasonic core energy generator runs through thecenter of the catheter. In embodiments, the ultrasonic core energygenerator includes a control unit configured to manage the generator. Aproximal end of the retrieval device 2800 includes leads plug into thecontrol unit, in embodiments.

In accordance with some aspects of the present specification, the firstand second units 2890, 2892 are manufactured as separate standaloneunits or devices. This is advantageous in that a physician may use thefirst unit 2890 with any third-party aspiration catheter. In someembodiments, the aspiration catheter 2835 is available with a pluralityof external diameters such as, but not limited to, 12 Fr, 16 Fr, 20 Fr,and 24 Fr (where Fr represents French scale or gauge system). In someembodiments, the syringe 2837 has an exemplary, non-limiting, volume of60 cubic centimeters.

In some embodiments, for use in treatment of pulmonary embolism a lengthof the delivery catheter 2848 is in a range of 80 cm to 160 cm,preferably 120 cm. In some embodiments, for use in treatment ofpulmonary embolism the aspiration catheter 2835 has different lengthsfor different external diameters. For example, an aspiration catheter of16 Fr has a length in a range of 70 cm to 160 cm, preferably 112 cm, anaspiration catheter of 20 Fr has a length in a range of 60 cm to 150 cm,preferably 105 cm or 106 cm, and an aspiration catheter of 24 Fr has alength in a range of 50 cm to 130 cm, preferably 90 cm. Also, in someembodiments, for use in treatment of pulmonary embolism (PE), theaspiration catheter of 20 Fr has a distal end or tip with a customizable270° bend whereas the aspiration catheter of 24 Fr has a flexible orbendable distal end or tip. In some embodiments, for use in treatment ofpulmonary embolism (PE), the suction source 2837 is a syringe having avolume ranging from 1 cc to 100 cc, and preferably a volume of 60 cc. Insome embodiments, for use in treatment of deep vein thrombosis (DVT) alength of the delivery catheter 2848 is in a range of 40 cm to 120 cm,preferably 80 cm. In some embodiments, for use in treatment of deep veinthrombosis a length of a 16 Fr aspiration catheter 2835 is in a range of45 cm to 80 cm, preferably 65 cm. In some embodiments, for use intreatment of deep vein thrombosis, the suction source 2837 is a syringehaving a volume ranging from 1 cc to 100 cc, and preferably a volume of60 cc. In some embodiments, for use in treatment of right heart/atrium,the 24 Fr aspiration catheter has a length of 90 cm. In someembodiments, for use in treatment of IVC/SVC (Inferior VenaCava/Superior Vena Cava), the 24 Fr aspiration catheter has a length of90 cm. In some embodiments, at least one pressure transducer or sensor2809 (such as, for example, a fiber-optic pressure sensor,electro-mechanical pressure sensor and hydraulic pressure sensor) ispositioned at a distal end of aspiration catheter 2835. In someembodiments, the at least one pressure transducer or sensor 2809 is inthe form of an elongated member that is co-extruded into the aspirationcatheter 2835 so that the elongated member runs along a full length ofthe aspiration catheter 2835. In embodiments, the pressure transducer orsensor 2809 is in electrical communication with electronic circuitrylocated in a handle 2802 of the first unit 2890. In embodiments, thehandle 2802 includes a pressure display 2821. In various embodiments,the pressure transducer or sensor 2809 is configured to sense a pressurechange or drop and, in particular, provide the physician with anindication that, as the occlusion is removed, there is an associatedchange of pressure indicative of a right side drop in right heartpressure. A right side drop in right heart pressure indicates that aproblematic occlusion is being successfully removed.

Referring again to FIGS. 28A to 28J, in embodiments, tip portion 2804 ofdevice 2800 has a proximal end 2850 and a distal end 2852. Duringoperation of the device 2800, the tip portion 2804 is inserted into, forexample, a blood vessel for removing an occlusion while the handleportion 2802 remains in an operator/user's hands. During insertion ofthe device 2800 into the blood vessel, the distal end 2852 of the tipportion 2804 enters the blood vessel first and is placed in closeproximity to the occlusion within the blood vessel by using the handle2802 to maneuver the insertion of the tip portion 2804 in a desiredposition in the blood vessel. The tip portion 2804 comprises a distalmember, element or body 2807, which in an embodiment, is a mechanicallyexpandable, rigid anchor fixedly attached proximate the distal end 2852of the tip portion 2804, and a proximal member, element or body 2806,which in an embodiment is a mechanically expandable pusher ball that isslidably mounted proximate the proximal end 2850 of the tip portion2804. The mechanical expansion is in contrast to a non-mechanicalexpansion occurring because a shape memory material is naturallyconfigured to adopt a pre-defined shape without mechanical forcerequiring to be applied.

In some alternate embodiments, the proximal element or body 2806 isconfigured as a mechanically expandable, rigid anchor fixedly attachedproximate to the proximal end 2850 of the tip portion 2804 while thedistal element or body 2807 is configured as a mechanically expandablepusher ball that is slidably or moveably mounted proximate the distalend 2852 of the tip portion 2804.

In various embodiments, the proximal and distal elements 2806, 2807 aresubstantially curved structures. In some embodiments, each of theproximal and distal elements 2806, 2807 is a three-dimensional (3D)shape. In some embodiments, the proximal and distal elements 2806, 2807are independent of one another yet mounted on a single delivery systemor device 2800. In one embodiment, the proximal 2806 member and thedistal member 2807 are braided structures made of interwoven wires suchthat each structure has a plurality of open areas (allowing egress fromoutside the member into the internal volume of the member) formed by thebraid. The open areas, relative to the total surface area of theproximal or distal member 2806, 2807, is in a range of 1% to 99% of thetotal surface area. In one embodiment, the proximal member 2806 has agreater percentage of open surface area than the distal member 2807,thereby allowing the proximal member 2806 to capture more clot materialand the distal member 2807 to function more as a barrier to materialflowing away from the device. The proximal member 2806 and/or distalmember 2807 may be of any shape, including linear, spherical, spheroid,elliptical, ellipsoid, conical, polygonal, cylindrical, stent, chalicecup, umbrella, concave structure, convex structure, half-sphere, sphere,windsock, dumbbell, star, polygon, lever, disc, or a combination of suchshapes.

In one embodiment, as shown in FIG. 28C, the proximal member 2806 isstructurally shaped as a first funnel 2886 having a neck 2888 directedalong an axis 2803 in a proximal direction and a second funnel 2887having a neck 2889 directed along the axis 2803 in a distal directionwherein the cup edge of the first funnel 2886 and the second 2887 areattached (in the form of contiguous wires) across a center axis 2891.Alternatively or additionally, in some embodiments, the distal member2807 is also structurally shaped similar to the proximal member 2806 interms of including a first funnel having a first neck directed along theaxis 2803 in a proximal direction and a second funnel having a secondneck directed along the axis 2803 in a distal direction wherein the cupedges of the first funnel and the second funnel are attached,optionally, in the form of contiguous wires, across a center axis). Insome embodiments, when either of or both of the proximal element 2806and/or the distal element 2807 is mechanically expanded, a proximalportion and a distal portion of the respective element expands firstfollowed by a center portion. In some embodiments, each of therespective proximal, distal and center portions of the proximal element2806 and the distal element 2807 may expand at different rates. In someembodiments, the proximal element 2806 and the distal element 2807 maybe heterogeneous, having different characteristics including, withoutlimitation, radial force (as described further below), shape, size (forexample, thickness, diameter), pore size (for example, mesh pore size oropen areas as described above), and external coating. In someembodiments, the proximal and distal elements 2806, 2807 may besubstantially similar in terms of the compositions and characteristics.

In some embodiments, the proximal and distal elements 2806, 2807 havesimilar braided structures that transition from a substantially linearstructure to a substantially disc structure, adopting one or more threedimensional geometric shapes (spherical, spheroid, elliptical,ellipsoid, conical, polygonal, cylindrical, stent, chalice cup,umbrella, concave structure, convex structure, half-sphere, sphere,windsock, dumbbell, star, polygon, lever, disk or a combination of suchshapes) during the transition. That is, the proximal element 2806 isdefined by a first braid structure while the distal element 2807 isdefined by a second braid structure, wherein the second braid structureis equivalent to the first braid structure, in embodiments. In otherembodiments, the second braid structure is not equivalent to the firstbraid structure.

As shown in FIG. 28L, the proximal element 2806 has a proximal portion28021 and a distal portion 28041. In some embodiments, the proximalportion 28021 has a denser braid relative to the distal portion 28041.That is, the proximal portion 28021 is defined by a braid or weavepattern that is more stiff, rigid, or dense as compared to the distalportion 28041. The proximal element 2806 has a braid or weave thatresults in an active radial expansion. In some embodiments, the proximalportion 28021 represents 30-70% of the total surface area of theproximal element 2806 while the distal portion 28041 represents 70-30%of the total surface area of the proximal element 2806. The distalelement 2807 has a proximal portion 28101 and a distal portion 28121. Incontrast to the proximal element 2806, the proximal portion 28101 of thedistal element 2807 has a less dense (stiff/rigid) braid than the distalportion 28121 of the distal element 2807. The distal element 2807 has abraid or weave that results in an active radial expansion. In someembodiments, the distal portion 28121 represents 30-70% of the totalsurface area of the distal element 2807 and the proximal portion 28101represents 70-30% of the surface area of the distal element 2807. Thus,in some embodiments, the proximal element 2806 is defined by a firstbraid structure while the distal element 2807 is defined by a secondbraid structure, wherein the second braid structure is equivalent to thefirst braid structure rotated 180 degrees. In embodiments, the differentbraid structures enable scraping of unwanted material or occlusion froma vessel wall as well as effective trapping of the unwanted material orocclusion within and/or between the proximal and distal elements 2806,2807 so that the material or occlusion is easily removed.

The tip portion 2804 is at least partially enclosed within the deliverycatheter 2848 (as shown in view 2870 of FIG. 28H) which when retracted(as shown in view 2872 of FIG. 28H) exposes at least the distal element2807 and the proximal element 2806 when the device 2800 is inserted andmaneuvered within the vascular system or non-vascular structures, byusing the handle portion 2802.

As stated above, in some embodiments, the distal element 2807 may becurved and take the form of a cylinder, stent, chalice cup, umbrella,concave structure, half-sphere, sphere, windsock, dumbbell, star,polygon, lever, or any other suitable shape configured for holding anocclusion and aiding retrieval of the occlusion. In some embodiments,the elongated member 2805, including the tip portion 2804, comprisesfour flexible telescoping tubes, that when manipulated together enablean operator/doctor to expand or contract the distal and proximalelements 2807, 2806 and move the proximal element 2806 axially, relativeto the distal element 2807 and vice versa, in order to dislodge andremove the occlusion. View 2874 of FIG. 28H illustrates the proximal anddistal elements 2806, 2807 fully expanded by manipulating the flexibletelescoping tubes using the handle 2802. In an embodiment, the proximalelement (pusher ball) 2806 is configured to move relative to the distalelement (rigid anchor) 2807 via manipulation of the flexible telescopingtubes to enable dislodging and removal of the occlusion, as is explainedin detail with reference to FIGS. 29A through 29D. View 2876 of FIG. 28Hillustrates the proximal element 2806 being moved axially towards thedistal element 2807 by manipulating the flexible telescoping tubes usingthe handle 2802.

In some embodiments, the distal and/or proximal elements 2807, 2806 arefabricated from a Nitinol wire mesh having a plurality of mesh pores,lattices or cells. In some less preferred embodiments, the distal and/orproximal elements 2807, 2806 are inflatable devices including, but notlimited to, inflatable balloons. In some embodiments, the distal andproximal elements 2807, 2806 are fabricated from different materials. Insome embodiments, the distal element 2807 is a wire mesh while theproximal element 2806 is an inflatable balloon. In some embodiments, thedistal element 2807 is an inflatable balloon while the proximal element2806 is a wire mesh.

In some embodiments, each of the proximal element 2806 and the distalelement 2807 may be characterized by their ability to apply a variableradial force by virtue of the mechanical expansion being applied to eachstructure and the elements' stiffness or rigidity across sub-regions orportions of the respective elements 2806, 2807. For example, in someembodiments, the expansion of each of the proximal and distal elements2806, 2807 to a first size (defined by an area or volume encompassed bythe element) may be characterized by a first radial force that firstsize can apply to surrounding materials. The expansion of each of theproximal and distal elements 2806, 2807 to a second size (defined by anarea or volume encompassed by the element that is larger than the firstsize) may be characterized by a second radial force that second size canapply to surrounding materials, where the second radial force isdifferent from the first radial force. In some embodiments, each of thefirst and second radial forces are in a range of 5 Newtons to 25Newtons, preferably 10 Newtons to 14 Newtons. The mechanical expansionallows for the intermittent, controlled expansion of the proximal anddistal elements 2806, 2807 so that they can adopt and retain the shapeof a first size (having a first area or volume), a second size (having asecond area or volume), a third size (having a third area or volume), ora fourth size (having a fourth area or volume) under the control of theuser and throughout the length of a procedure where the fourth size isbigger than the third size which is bigger than the second size which isbigger than the first size.

In some embodiments, each of the proximal element 2806 and the distalelement 2807 may be characterized by their ability to resist anapplication of a radial force, thereby maintaining its expanded shape,by virtue of the mechanical expansion being applied to each structureand the elements' stiffness or rigidity across sub-regions of therespective elements 2806, 2807. For example, in some embodiments, theexpansion of each of the proximal and distal elements 2806, 2807 to afirst size (defined by an area or volume encompassed by the element) maybe characterized by an ability to resist (and therefore avoid collapseor compression of the first size) from a first radial force. Theexpansion of each of the proximal and distal elements 2806, 2807 to asecond size (defined by an area or volume encompassed by the elementthat is larger than the first size) may be characterized by an abilityto resist (and therefore avoid collapse or compression of the secondsize) from a second radial force that is different from the first radialforce. In some embodiments, each of the first and second radial forcesare in a range of 5 Newtons to 25 Newtons, preferably 9 to 20 Newtons,more preferably 10 Newtons to 14 Newtons. The mechanical expansionallows for the intermittent, controlled expansion of the proximal anddistal elements 2806, 2807 so that they can adopt and retain the shapeof a first size (having a first area or volume), a second size (having asecond area or volume), a third size (having a third area or volume), ora fourth size (having a fourth area or volume) under the control of theuser and throughout the length of a procedure where the fourth size isbigger than the third size which is bigger than the second size which isbigger than the first size. It should further be appreciated that atleast one of the proximal and distal elements 2806, 2807 area adapted tonot collapse or compress when positioned against blood flow that appliesa hydrostatic pressure in a range of 80 mm Hg to 250 mm Hg. This isparticularly valuable in arterial clot removal where the hydrostaticpressure level often causes other structures, particularlyself-expanding structures, to compress or collapse.

In one embodiment, a physician uses any of the embodiments disclosedherein by a) placing the distal element distal to the occlusion, b)placing the proximal element proximal to the occlusion, c) expand eachof the proximal and distal elements to a diameter, width, or volume thatis greater than or equal to the diameter, width or volume of the vessellumen it is positioned within of vessel (if greater than, it may beequal to or up to 150%, preferably around 110% to 130%, more preferably120%), d) sandwich the thrombus between the distal and proximalelements, e) apply aspiration, f) move the proximal element to pull thethrombus to the catheter, g) partially collapse the proximal and distalelements to move both toward the catheter, h) collapse both elements topull them back into the catheter, with the thrombus, and remove thecatheter from the patient. The distal element may optionally act asembolic protection to protect against clot material breaking free andflowing away from the procedure site.

In some embodiments, the proximal element 2806 and the distal element2807 may have anti-platelet coating to reduce adhesion and provide aless thrombogenic environment during clinical application. In someembodiments, the proximal element 2806 and the distal element 2807 andany material (for example, wires and/or tubes) between these elements,may be coated with control release agents including, but not limited to,thrombolytic agents.

Preferably, the distal element 2807 is rigid and holds/maintains apredefined shape after expansion. In particular, it is preferred that,when deployed within a patient's vessel, a degree of fixation achievedby the distal element 2807 is greater than that achieved by the proximalelement 2806, making the proximal element 2806 comparatively more mobilethan the distal element 2807. Having a distal member that is lesssusceptible to collapse and/or more resistant to force, ensures that thedistal member can anchor and fix the device within the vessel andprovide the opposing leverage to ensure the proximal member, whenaxially moved, can pull the clot material toward the open catheter. Inalternate embodiments, however, the proximal element 2806 is rigid andholds/maintains a predefined shape after expansion while the distalelement 2807 is relatively more mobile than the proximal element 2806.In such embodiments, the degree of fixation achieved by the proximalelement 2806 is greater than that achieved by the distal element 2807.Consequently, in such embodiments, the proximal element 2806 is lesssusceptible to collapse and/or more resistant to force, ensuring thatthe proximal element 2806 can anchor and fix the device within thevessel and provide the opposing leverage to ensure the distal element2807, when axially moved, can pull the clot material toward the opencatheter.

Fixation may be achieved by means of radial opposition against apatient's vessel wall, engagement within or beyond a distal portion ofan occlusion requiring removal, deployment around distal anatomicalfeatures (such as a vascular bifurcation or curve in the vasculature),or any combination of these. Aspects that may selectively enhance orimpede the relative fixation enabled by the proximal and distal elements2806, 2807 include radial force or stiffness, expanded diameter, braiddensity, braid wire size, deployed length, deployed shape, wire geometryand surface finish, surface treatments and coatings, or other means thatallow for amplification or dampening of frictional engagement of theelements 2806, 2807 with the occlusion and surrounding vasculature.

In embodiments, the proximal element 2806 is equally or less stiff/rigidthan the distal element 2807 by a ratio of less than or equal to 1:10.In embodiments, the relative stiffness or rigidity relationship isinverted with the distal element 2807 being equally or less stiff thanthe proximal element 2806 by a ratio of less than or equal to 1:10. Bymodulating the manufactured relative radial force, stiffness or rigidityof the proximal and distal elements 2806, 2807, a desired balance ofrelative anchoring force to maceration potential can be achieved.

As previously stated, higher stiffness, rigidity or degree of fixationof the distal element 2807, relative to the proximal element 2806,provides an effective anchoring function when positioned within avascular system or non-vascular structures. During a procedure, theanchored distal element 2807 provides an opposing anchoring force whenthe proximal element 2806, having relatively lesser stiffness, rigidityor degree of fixation, is moved or pushed axially towards the distalelement 2807 to dislodge an occlusion. This provides an operator animproved ability to apply pressure, through the pushing manipulation ofthe proximal element 2806, in order to dislodge the occlusion. Thus, invarious embodiments, by adjusting the characteristics (of the proximaland distal elements 2806, 2807) such as the radial force, shape, size(for example, thickness, diameter), pore size (for example, mesh poresize in embodiments where at least one of the two elements 2806, 2807 isfabricated from a wire mesh) and external coating a desired stiffness,rigidity or flexibility of the retrieval device 2800 may be obtained.With the desired stiffness, rigidity or flexibility the retrieval device2800 may be adapted to extract or remove a variety of obstructions suchas, for example, stones, pulmonary emboli and deep vein clots.

In sum, the distal member has a higher degree of rigidity and greaterdegree of porosity as compared to the proximal member. This is achievedby the distal member having at least one of a shape, wire thickness,average pore size, total porosity, total open surface area to totalsurface area ratio, and/or coating that is different from the proximalmember. As a result, when expanded to any number of a plurality ofsizes, the distal member is preferably more resistant to changing itssize or shape upon application of an external force as compared to theproximal member. In some embodiments, that external force is in a rangeof 1 newton to 50 Newtons and any increment therein, more preferably 8newton to 20 Newton, even more preferably 9 newton to 15 newton.Additionally, as a result, when expanded to the same size as theproximal member, the distal member is preferably less porous, meaningthat it has less open surface area relative to total surface area, thanthe proximal member.

In embodiments, the elongated member 2805, including the tip portion2804, comprises a plurality of telescoping tubes (also referred to,alternatively, as shafts), such as 1-6 or preferably 4, which are alsodescribed with reference to FIGS. 29A-29D. As shown in FIG. 28B (in anexpanded form), a first tube 2830 is shown projecting distally from adistal end 2854 of the delivery catheter 2848. The first tube 2830 iscoupled with a second tube 2825 that is coupled with a third tube 2827which, in turn, is coupled with a fourth/anchor tube 2816. Thefourth/anchor tube 2816 forms the distal end 2852 of the tip portion2804. In an embodiment, the four tubes 2830, 2825, 2827 and 2816 arearranged as a coaxial array of telescopic tubes, all of which aredesigned to be able to move axially relative to one another. In anembodiment, the first tube 2830 is concentrically positioned around thesecond tube 2825, the second tube 2825 is concentrically positionedaround the third tube 2827, and the third tube 2827 is concentricallypositioned around the fourth tube 2816. In embodiments, the fourtelescoping tubes 2830, 2825, 2827 and 2816 can be axially expanded orcontracted relative to each other by using the handle portion 2802. Inan embodiment, the telescoping tubes 2830, 2825, 2827 and 2816 are madeof Nitinol.

In an embodiment, the distal element 2807 has a proximal end 2856 and adistal end 2858. As shown, the distal end 2858 is fixedly connected onthe fourth tube 2816 at the anchor nose 2834, while the proximal end2856 is fixedly connected to a point 2815 on the third tube 2827 in bothexpanded and non-expanded states of the distal element 2807. Inembodiments, the wire mesh 2813 is only attached at points 2834 and2815, respectively, of an exterior surface of the fourth tube 2816 andthe third tube 2827, while the remaining portion of the wire mesh 2813is unattached and therefore free to expand or contract. In someembodiments, in a non-expanded or collapsed state, the distal element2807 (comprising a plurality of wires) forms a generally tubular wiremesh 2813 and is concentrically positioned around a lumen of the fourthtube 2816. It should be appreciated that, while the term “tube” is usedto describe the telescoping structures, any type of cylindrical, hollowwire, solid wire, or other elongated structure may be used and the term“tube” or “shaft” is just intended to cover each of these structures.

Upon axial compression of the third tube 2827 relative to the fourthtube 2816, the wire mesh 2813 expands radially around the lumen of thefourth tube 2816. Similarly, upon axial decompression of the third tube2827 relative to the fourth tube 2816, the wire mesh 2813 is induced tocompress or contract radially around the lumen of the fourth tube 2816.In some embodiments, in order to expand or contract the distal element2807 the fourth tube 2816 is moved axially while the first, second andthird tubes 2830, 2825, 2827 remain stationary. In some embodiments,initial expansion of the distal element 2807, as induced by relativeaxial motion of the third tube 2827 and the fourth tube 2816, is suchthat the distal element 2807 first takes a shape similar to that of theproximal element 2806 (the shape of the proximal element 2806 beingsubstantially elliptical, in one embodiment). Further relative axialmovement of the third tube 2827 and the fourth tube 2816 induces aninversion in at least a portion of the wire mesh 2813 such that theproximal end 2856 collapses inside the distal end 2858, forming achalice or a cup/concave shape as shown in FIGS. 28B and 28E.Consequently, in some embodiments, the expanded distal element 2807 hasa shape substantially equivalent to a semi-sphere or cone with aninterior surface 2811 folded into the semi-sphere to form a chalice orcup-like structure which may be used to hold an occlusion before removalfrom a patient's body. In an embodiment a distance between the twoattachment points 2834 and 2815 of the wire mesh 2813 rangesapproximately from 1 mm to 100 mm.

Stated differently, relative axial movement of the third tube 2827 andthe fourth tube 2816 causes the proximal end 2856 and the distal end2858 to move closer to each other, the material comprising the distalelement 2807 and extending between the ends 2856 and 2858 is compressedand therefore expands outward. In contrast, as the proximal end 2856 andthe distal end 2858 move away from each other, the material comprisingthe distal element 2807 and extending between the ends 2856 and 2858 isstretched and therefore collapses down to, and elongates along, a bodylumen. Thus, the distal element 2807 expands by having the proximal end2856 move distally and contracts by having the proximal end 2856 moveproximally relative to the distal end 2858.

In some embodiments, the anchor nose 2834 is configured as a corkscrewstructure such that, as the tip portion 2804 is advanced towards a clot(within a vessel lumen) the tip portion 2804 is rotated to “screw into”and break up the clot material.

Referring now to FIGS. 28B, 28C and 28D, in an embodiment, the proximalelement 2806 has a proximal end 2860 and a distal end 2862. The distalend 2862 of the proximal element 2806 is fixedly attached to the secondtube 2825 at a point 2828, while the proximal end 2860 is fixedlyattached to the first tube 2830 at a point 2829 in both expanded andnon-expanded states of the proximal element 2806. In variousembodiments, in a non-expanded state, the proximal element 2806(comprising a plurality of wires) forms a wire mesh 2826 concentricallypositioned around a lumen of the second tube 2825.

In embodiments, a portion of the wire mesh 2826 is only attached atpoints 2828 and 2829, of an exterior surface of the second tube 2825 andthe first tube 2830, respectively, while the remaining portion of thewire mesh 2826 is unattached and therefore free to expand or contract.Upon axial compression of the first tube 2830 relative to the secondtube 2825, the wire mesh 2826 is induced to expand radially around thelumen of the second tube 2825. Similarly, upon axial decompression ofthe first tube 2830 relative to the second tube 2825, the wire mesh 2826is induced to compress or contract radially around the lumen of thesecond tube 2825. In some embodiments, in order to expand or contractthe proximal element 2806 the first tube 2830 is moved axially while thesecond, third, and fourth tubes 2825, 2827, 2816 remain stationary.Stated differently, relative axial movement of the first tube 2830 andthe second tube 2825 causes the proximal end 2860 and the distal end2862 to move closer to each other, whereby the material comprising theproximal element 2806 and extending between the ends 2860 and 2862 iscompressed and therefore expands outward. In contrast, as the proximalend 2860 and the distal end 2862 move away from each other, the materialcomprising the proximal element 2806 and extending between the ends 2860and 2862 is stretched and therefore collapses down to, and elongatesalong, a body lumen. Thus, the proximal element 2806 expands by havingthe proximal end 2860 move distally and contracts by having the proximalend 2860 move proximally relative to the distal end 2862.

In an embodiment, in an expanded state the proximal element 2806approximates an elliptical shape wherein, at least a portion of the wiremesh 2826 lies approximately perpendicular to the lumen of the secondtube 2825. In an embodiment, a diameter of an expanded proximal element2806 is approximately 18 mm. In some embodiments, a fully expandedproximal element 2806 is substantially elliptical or disc-shaped asshown in FIGS. 28C and 28D, while in a transient or less expanded statethe proximal element 2806 may take different curved shapes such as, forexample, substantially spherical. In some embodiments, a fully expandedproximal element 2806 may be substantially spherical shaped while in atransient or less expanded state the proximal element 2806 may take asubstantially elliptical shape.

As previously discussed, in various embodiments, in an expanded statethe proximal element 2806 may take the form of a cylinder, stent,chalice cup, umbrella, concave structure, half-sphere, sphere, windsock,dumbbell, star, polygon, lever, or any other suitable shape configuredfor aiding retrieval of the occlusion. It should be appreciated that inan expanded state, in some embodiments, the proximal element 2806 maytake on a first shape while the distal element 2807 may take on a secondshape. In some embodiments, the first shape is different from the secondshape. In some embodiments, the first and second shapes aresubstantially similar. In some embodiments, the proximal and/or distalelements 2806, 2807 can be turned and rotated as motorized units. Insuch an embodiment, a small motor positioned in or proximate the handleis coupled to each of the proximal and/or distal elements 2806, 2807and, upon actuation, the motor causes one of or both the proximal and/ordistal elements 2806, 2807 to move or rotate.

Referring now to FIGS. 28A, 28G and 28J, in an embodiment, the handleportion 2802 comprises a groove 2812 running longitudinally along alength of the handle 2802. In an embodiment a distance between a distalend 2865 of the handle portion 2802 and the distal end 2852 of the tipportion 2804 is in a range of 0.5 mm to 110 cm, preferably 1 mm to 100mm. A first actuator, knob, slider or button 2814, configured to enablethe user to mechanically expand or contract the distal element 2807, iscoupled with the third tube 2827 and is slidably fitted into the groove2812 such that the first slider 2814 may be slid forward (that is,distally) towards the tip portion 2804 or backwards (that is,proximally) away from the tip portion 2804. The fourth tube 2816 isconnected to the distal element 2807 at point 2834 while the third tube2827 is connected to the distal element 2807 at point 2815. A slidingmovement of the third tube 2827 relative to the fourth tube 2816 inducesand aids in the expansion and contraction of the distal element 2807.

It should be appreciated that, in alternate embodiments, the firstactuator, knob, slider or button 2814 is coupled to the fourth tube 2816so that a sliding movement of the fourth tube 2827 (using the firstactuator, knob, slider or button 2814) relative to the third tube 2827induces and aids in the expansion and contraction of the distal element2807. In other words, the first actuator, knob, slider or button 2814may be coupled to either the third tube 2827 or the fourth tube 2816 inorder to impart a sliding movement of the third and fourth tubes 2827,2816 relative to each other.

Sliding the first knob 2814 within the groove 2812 towards the tipportion 2804 causes the third tube 2827 to telescope into the fourthtube 2816 thereby inducing an axial compression of the third tube 2827relative to the fourth tube 2816 and consequently of the distal element2807 between the proximal and distal ends 2856, 2858 of the wire mesh2813. This causes the wire mesh 2813 (and therefore the distal element2807) to expand radially around the lumen of the fourth tube 2816 andassume an expanded chalice, cup/concave shape having a diameter greaterthan a diameter in an unexpanded state. This kind of mechanicalexpansion of the distal element 2807 is preferred as this expansionprovides a user control over the diameter of the distal element 2807 inan expanded state and, also provides a rigid structure that is lesssusceptible to collapse when placed under pressure. Providing aphysician control over the expansion size means that a physician may setone of a plurality of different expansion sizes and, upon setting thatexpansion size, the proximal or distal element maintains that expansionsize even upon application of an external force in the ranges disclosedherein, such as 9 newtons to 15 newtons. In one embodiment, a proximalelement and/or distal element (first expansion member and/or secondexpansion member) expands upon moving the at least one actuationmechanism (slider, knob, lever, etc.) distally and wherein saidexpansion causes at least one of the first expandable member and thesecond expandable member to transform from a substantially linearconfiguration to a first shape, second shape or third shape depending onhow far the at least one actuation mechanism has been moved distally.The first shape, second shape or third shape is at least one of aspherical shape, an elliptical shape, a conical shape, a polygonalshape, a cylindrical shape, a shape of a stent, a shape of a chalicecup, a shape of an umbrella, a concave shape, a convex shape, ahalf-sphere shape, a windsock shape, a dumbbell shape, a star shape, orany combination of said shapes. The first shape has a first outersurface and a furthest distance from the first outer surface to theelongated member is defined by a first distance; the second shape has asecond outer surface and a furthest distance from the second outersurface to the elongated member is defined by a second distance; thethird shape has a third outer surface and a furthest distance from thethird outer surface to the elongated member is defined by a thirddistance and the third distance is greater than the second distance andwherein the second distance is greater than the first distance. Thefirst shape is configured to maintain said first distance even upon anapplication of an external force to the first outer surface in a rangeof 9 newtons to 15 newtons, wherein the second shape is configured tomaintain said second distance even upon an application of an externalforce to the second outer surface in a range of 9 newtons to 15 newtons,and wherein the third shape is configured to maintain said thirddistance even upon an application of an external force to the thirdouter surface in a range of 9 newtons to 15 newtons.

Similarly, sliding the first knob 2814 within the groove 2812 away fromthe tip portion 2804 causes the third tube 2827 to telescope and expandout of the fourth tube 2816 thereby inducing an axial decompression ofthe distal element 2807 between the proximal and distal ends 2856, 2858of the wire mesh 2813. This causes the wire mesh 2813 (and therefore thedistal element 2807) to contract radially around the lumen of the fourthtube 2816 and assume an unexpanded substantially cylindrical shapehaving a diameter lesser than a diameter in an expanded state.

In some embodiments, the distal element 2807 assumes a substantiallycylindrical shape when in a fully collapsed or unexpanded state, asubstantially elliptical shape when in a partially expanded state and aconcave, umbrella, half-sphere, sphere, windsock, dumbbell, star,polygon, chalice or cup-like shape when in a fully expanded state.

In some embodiments, the first knob 2814 locks (cannot be moved furtherforward) in a position in the groove 2812 when the distal element 2807has expanded to a maximum diameter, which in an embodiment isapproximately 25 mm. Thus, sliding the first knob 2814 forward enablesthe user to expand the distal element 2807 to a plurality ofintermediate diameters and up to a maximum permissible diameter. In someembodiments, the first knob 2814 is provided with a “clutch” feature sothat, when opposing pressure is experienced from walls of a blood vesselduring expansion of the distal element 2807, the “clutch” clicks in sothat the user does not over expand. This feature is advantageous sinceit prevents the user from damaging the blood vessel due to overexpansion of the distal element 2807.

In various embodiments, the distal element 2807 may expand to a diameterdepending upon an application/functional use of the device 2800. Forexample, for use in treatment of pulmonary/large vessel having adiameter of up to 20 mm, the diameter of an expanded distal element 2807ranges from 10 mm to 25 mm; for use in treatment of peripheral or deepvein thrombosis vessel having a diameter ranging from 5 mm to 10 mm, thediameter of an expanded distal element 2807 ranges from 3 mm to 12 mm;for use in treatment of neuro vessels, the diameter of an expandeddistal element 2807 ranges from 2 mm to 10 mm; for use in retrieval ofan occlusion in the inferior vena cava (IVC) vessels, the diameter of anexpanded distal element 2807 ranges from 35 mm to 40 mm. In someembodiments, for use in treatment of pulmonary embolism, each of theproximal and distal elements 2806, 2807 has an outer diameter rangingfrom 3 mm to 16 mm. In some embodiments, for use in treatment ofpulmonary embolism, each of the proximal and distal elements has amaximum outer diameter of 16 mm. In some embodiments, for use intreatment of pulmonary embolism, the delivery catheter is of 9 Fr. Insome embodiments, for use in treatment of deep vein thrombosis, each ofthe proximal and distal elements 2806, 2807 has an outer diameterranging from 3 mm to 20 mm. In some embodiments, for use in treatment ofdeep vein thrombosis, the proximal element 2806 has a maximum outerdiameter of 16 mm and the distal element 2807 has a maximum outerdiameter of 20 mm.

In an embodiment, for application of the retrieval device 2800 intreatment of pulmonary embolism the proximal element 2806 is designedwith a larger diameter as compared to the distal element 2807. In anembodiment, if a diameter of the distal element 2807 is 16 mm, diameterof the proximal element 2806 is 20 mm, as the internal diameter of apatient's blood vessels tapers down distally. In another embodiment, ifa diameter of the distal element 2807 is 5 mm, then a diameter of theproximal element 2806 is 20 mm. In an embodiment, for application of theretrieval device 2800 in treatment of deep vein thrombosis the proximalelement 2806 is designed with a smaller diameter as compared to thedistal element 2807. In an embodiment, if a diameter of the distalelement 2807 is 16 mm, then a diameter of the proximal element 2806 is14 mm, as in this case, the internal diameter of a patient's bloodvessels is larger proximally. In another embodiment, if a diameter ofthe distal element 2807 is 16 mm then a diameter of the proximal element2806 is 8 mm.

In various embodiments, in fully expanded state, each of the proximaland distal elements 2806, 2807 has a diameter ranging from 5 mm to 30mm, preferably 10 mm to 25 mm, and more preferably 10 mm to 20 mm.

In embodiments, the groove 2812 contains a series of interlockingfeatures along its length such that the first knob 2814 can beselectively engaged or disengaged from a locked position in the handle2802 at a plurality of expanded diameters for the distal element 2807.

Additionally, the handle portion 2802 includes a second actuator, knob,slider or button 2818 configured to enable the user to mechanicallyexpand or contract the proximal element 2806. Additionally, the handleportion 2802 includes a third actuator, knob, slider or button 2820configured to enable the user to mechanically slide the proximal element2806 forward towards the distal element 2807 or backwards away from thedistal element 2807 that remains stationary. Alternatively, the thirdactuator, knob, slider or button 2820 is configured to enable the userto mechanically slide the distal element 2807 back towards the proximalelement 2806 or forwards away from the proximal element 2806 thatremains stationary. The second and third knobs 2818, 2820 are slidablyfitted into the groove 2812. In some embodiments, the second slider 2818is coupled with the first tube 2830 to enable the user to mechanicallyexpand or contract the proximal element 2806. Alternatively, the secondslider 2818 may be coupled with the second tube 2825 to enable the userto mechanically expand or contract the proximal element 2806.

In some embodiments, the third slider 2820 is coupled with the first andsecond tubes 2830, 2825 such that a sliding movement of the third slider2820 towards or away from the tip portion 2804 causes the proximalelement 2806 to slide towards or away from the distal element 2807(while the third and fourth tubes 2827, 2816 remain stationary). Inalternative embodiments, the third slider 2820 is coupled with the thirdand fourth tubes 2827, 2816 such that a sliding movement of the thirdslider 2820 towards or away from the tip portion 2804 causes the distalelement 2807 to slide away from or towards the proximal element 2806(while the first and second tubes 2830, 2825 remain stationary).

In some embodiments, the first tube 2830 is connected to the proximalelement 2806 at the point 2829 while the second tube 2825 is connectedto the proximal element 2806 at the point 2828. A sliding movement ofthe first tube 2830 relative to the second tube 2825 aids in theexpansion and contraction of the proximal element 2806. Upon axialcompression of the first tube 2830 relative to the second tube 2825, thewire mesh 2826 is induced to expand radially around the lumen of thesecond tube 2825.

In some embodiments, when the second slider 2818 is moved or slid in thegroove 2812 towards the tip portion 2804, this causes the first tube2830 to telescope into the second tube 2825, thereby inducing an axialcompression of the first tube 2830 relative to the second tube 2825.Consequently, the proximal element 2806 is caused to expand to a desireddiameter. When the second slider 2818 is moved away from the tip portion2804 the first tube 2830 is caused to telescope out of the second tube2825 thereby inducing an axial decompression (or elongation) of thefirst tube 2830 relative to the second tube 2825 between the proximaland distal ends 2829, 2828 of the wire mesh 2826. This causes the wiremesh 2826 (and therefore the proximal element 2806) to contract radiallyaround the lumen of the second tube 2825 and assume an unexpanded shapehaving a diameter lesser than a diameter in an expanded state or assumea fully unexpanded state.

In some embodiments, when the third slider 2820 is moved in the groove2812 towards the tip portion 2804, the proximal element 2806 is causedto slide distally away from the handle 2802 and towards the distalelement 2807, whereas when the third knob 2820 is moved away from thetip portion 2804 the proximal element 2806 is caused to slide proximallytowards the handle portion 2802 and away from the distal element 2807.

In an embodiment, a diameter of a fully expanded proximal element 2806is approximately 18 mm. In various embodiments, the proximal element2806 may expand to a diameter depending upon an application/functionaluse of the device 2800. For example, for use in treatment of apulmonary/large vessel having a diameter of up to 20 mm, the diameter ofan expanded proximal element 2806 ranges from 10 mm to 25 mm; for use intreatment of a peripheral/DVT vessel having a diameter ranging from 5 mmto 10 mm, the diameter of an expanded proximal element 2806 ranges from3 mm to 12 mm; for use in treatment of neuro vessels, the diameter of anexpanded proximal element 2806 ranges from 2 mm to 10 mm; for use inretrieval of an occlusion in the inferior vena cava (IVC) vessels, thediameter of an expanded proximal element 2806 ranges from 35 mm to 40mm.

In some embodiments, the second slider 2818 locks (and thus, cannot bemoved further forward) in a position in the groove 2812 when theproximal element 2806 has expanded to a maximum diameter. Thus, slidingthe second slider 2818 forward enables the user to expand the proximalelement 2806 to a plurality of intermediate diameters and up to amaximum permissible diameter. In some embodiments, the second slider2818 is provided with a “clutch” feature so that, when opposing pressureis experienced from walls of a blood vessel during expansion of theproximal element 2806, the “clutch” clicks in so that the user does notover expand. This feature is advantageous since it prevents the userfrom damaging the blood vessel due to over expansion of the proximalelement 2806.

In various embodiments, the third slider 2820 may be configured to movesynchronously along with the second slider 2818 toward the tip portion2804 and/or in an opposing direction away from the tip portion 2804 fordislodging an occlusion and placing it in the distal element 2807. Insome embodiments, the groove 2812 has a series of interlocking featuresalong its length such that the second slider 2818 can be selectivelyengaged or disengaged from a locked position in the handle 2802 at aplurality of expanded diameters for the proximal element 2806.

In some embodiments, the device 2800 utilizes a lead-screw mechanism forcontinuous adjustment of the diameters of the proximal and distalelements 2806, 2807, so that the corresponding second slider 2818 andfirst slider 2814 may be advanced or retracted to an infinitely variablenumber of positions in the groove 2812 and may be held in a desiredposition by using a friction based locking mechanism, in order for theproximal and distal elements 2806, 2807 to attain a desired diameter. Inan embodiment, a non-backdriving thread pattern in the lead-screw isused to provide a friction-brake when not actuated by the user, enablingcontinuous adjustment of the diameters of expanded proximal and distalelements 2806, 2807.

In embodiments, the fourth tube 2816 and the third tube 2827 aretelescoped together to cause the distal element 2807 to expand orcontract, and the second tube 2825 and the first tube 2830 aretelescoped together, to cause the proximal element 2806 to expand orcontract. In an embodiment, by moving the third slider 2820, leading toadvancing or retracting of the second tube 2825 and the first tube 2830together as one, the relative positions of the proximal element 2806 andthe distal element 2807 may be adjusted in an expanded or collapsedstate. In an alternate embodiment, by moving the third slider 2820 whichleads to advancing or retracting of the third tube 2827 and the fourthtube 2816 together as one, the relative positions of the proximalelement 2806 and the distal element 2807 may be adjusted in an expandedor collapsed state.

In an embodiment, a distance between the proximal element 2806 and thedistal element 2807 ranges between 2 mm to 60 mm. Stated differently,the third knob 2820 may be actuated to cause the proximal element 2806to move distally towards the distal element 2807 until a minimumdistance between the proximal and distal elements 2806, 2807 is 2 mm.Similarly, the third slider may be actuated to cause the proximalelement 2806 to move proximally and away from the distal element 2807until a maximum distance between the proximal and distal elements 2806,2807 is 60 mm. In embodiments, the second slider 2818 may be positionedat several different locations/positions along the length of the groove2812, wherein each of the locations/positions corresponds to a differentdegree of expansion of the proximal element 2806, and hence a differentshape of the proximal element 2806.

In some embodiments, a minimum distance between the proximal and distalelements 2806, 2807 ranges from 0 to 5 mm and a maximum distance betweenthe proximal and distal elements 2806, 2807 ranges from 60 mm to 400 mm.

In some embodiments, the first tube 2830 extends from the handle portion2802 to the proximal element 2806 and is co-axial with the second tube2825, while the third tube 2827 extends from the handle portion 2802 tothe distal element 2807 and is co-axial with the fourth tube 2816 whichis fixedly attached to the anchor nose 2834. In some embodiments, thesecond tube 2825 and the fourth tube 2816 provide a fixed distalposition of the corresponding wire mesh (proximal or distal elements2806, 2807 respectively) against which the telescoping first tube 2830and the third tube 2827 actuate to expand the proximal or distalelements 2806, 2807, respectively. The anchor nose 2834 provides atermination and fixation point for the distal element 2807 and, in anembodiment, performs a secondary function of a radiopaque marker. Invarious embodiments, diameters of the telescoping tubes 2830, 2825, 2827and 2816 range from 0.010 mm to 1 mm for neurovascular and peripheralapplications, and 1 mm to 3 mm for pulmonary and larger applications. Insome embodiments, the fourth tube 2816 may be a solid wire instead of ahollow tube. In an embodiment, a fully expanded distal element 2807 maybe concave in shape or may be shaped like a chalice, cup, or ahalf-sphere as shown in FIGS. 28E and 28F, while in a less expandedstate the distal element 2807 may take different shapes.

Referring back to FIGS. 28A-28G, and 28J, in an embodiment, in order toretrieve an occlusion from a lumen of a patient, the delivery catheter2848 is positioned near the occlusion (using the handle 2802) and thetip portion 2804 is positioned within, or all the way through, theocclusion. Once the occlusion matter is captured between the proximalelement 2806 and the distal element 2807, the syringe 2837 is actuatedto generate suction at an aspiration line 2824 and aspirate theocclusion matter through the aspiration catheter 2835.

Thus, in various embodiments, the proximal and distal elements 2806,2807 expand to a particular diameter and a particular radial force,thereby allowing trapping and curettage of thrombus or clot materialfrom a vessel lumen and wall. In some embodiments, the retrieval device2800 utilizes its adjustable radial forces and its adjustable size toactively curettage the wall of an artery or vein. In some embodiments,the retrieval device 2800 enables removal of thrombus by simultaneouslycapturing, compressing, dragging and curetting thrombotic material fromvessel walls. In one embodiment, the proximal element is configured tocapture, and/or contain, a size of clot or thrombus material in a volumerange of 1 mm to 100 cm.

In some embodiments, the handle portion 2802 includes a plurality ofgradations such as, for example and by way of example only, threegradations of low, medium and high, five gradations ranging from low tohigh or eight gradations ranging from low to high. Each gradation isindicative of a corresponding predefined diameter of the proximal anddistal elements in expanded states. The three slide buttons 2814, 2818,2820 can be actuated to any one of the plurality of gradations and thendétente to that position.

While in some embodiments, the handle portion 2802 includes threebuttons 2814, 2818, 2820 to manipulate the proximal and distal elements2806, 2807, in alternate embodiments fewer than three buttons may beused. For example, in some embodiments, a clinician's use of the device2800 is monitored over a predefined number of uses or operations of thedevice 2800 while performing mechanical thrombectomy procedures. Basedon the monitoring, a preferred sequence of deployment of the proximaland distal elements 2806, 2807 is determined and data indicative of thedeployment sequence is stored in a memory (residing within the handleportion 2802 or remote from the handle portion 2802).

As a non-limiting illustration, the deployment sequence may include(after placing the device 2800 proximate an occlusion) expanding thedistal element first followed by expanding the proximal element.Consequently, a first button (when actuated) is programmed to carry outthe deployment sequence and a second button is then used to reciprocatethe proximal element axially. Thus, in this illustration, only twobuttons are required to manipulate the proximal and distal elements2806, 2807. In another case scenario, the deployment sequence mayinclude expanding the distal element, expanding the proximal element andthen moving the proximal element axially fore and aft for a cycle of 5reciprocations. Consequently, a first button (when actuated) isprogrammed to carry out the deployment sequence. Of course, in someembodiments, second and third buttons may still be used manually afterthe deployment sequence has been completed by the programmed button. Insome embodiments, an Artificial Intelligence (AI) algorithm implementsthe deployment sequence, once the device 2800 is placed in-vivo, toautomatically expand the proximal and distal elements and/or move theproximal element axially.

It should also be appreciated that the three buttons 2814, 2818, 2820may be sliders, knobs, levers, dials, push buttons or a combinationthereof. For example, first and second knobs may be used toexpand/contract the proximal and distal elements respectively while apush button may be used to move the proximal element axially. In anotherexample, first, second and third levers may be actuated to generate pumpactions to expand/contract the proximal and distal elements and to movethe proximal element axially. In yet another example, first and seconddials may be actuated clockwise/counter-clockwise to expand/contract theproximal and distal elements respectively while a slider button may beused to move the proximal element axially. Push buttons may use servosand ball screws to expand/contract the proximal and distal elements andto move the proximal element axially. Knobs may be circumferentiallydesigned on the handle portion 2802.

In some embodiments, the distal and/or proximal elements 2807, 2806 areself-expanding Nitinol wire meshes. In some embodiments, theself-expanding distal and/or proximal elements 2807, 2806 are restrainedby the handle portion 2802. In some embodiments, the self-expandingdistal and/or proximal elements 2807, 2806 are constrained by a sheathor ring that covers the tip portion 2804. The self-expanding distaland/or proximal elements 2807, 2806 expand when the constraining sheathor ring is removed. Thus, in some embodiments, the self-expanding distaland/or proximal elements 2807, 2806 are configured for expansion basedon removal of a constraining or resisting member.

In some embodiments, the retrieval device 2800, within the catheter2835, has a hypo tube and a central wire is positioned within the hypotube. The distal element 2807 is positioned on the wire while theproximal element 2806 is positioned on the hypo tube at a fixedlocation. Once the device 2800 is in place, the central wire is passedout of the catheter 2835 and the distal element 2807 becomesunconstrained and automatically pops open to a preset size or outerdiameter (self-expanding). With the central wire and distal element 2807in place, the hypo tube is then moved axially. Because the hypo tube isover the wire, moving the hypo tube automatically moves the proximalelement 2806 relative to the distal element 2807. The hypo tube is moveduntil the proximal element 2806 also pops open. The physician then movesthe hypo tube relative to the wire (which is fixed in place) to move theproximal element 2806 relative to the distal element 2807 and scrub outthe clot/occlusion.

FIG. 28K illustrates a longitudinal cross-sectional view of the handle2802 of the retrieval device 2800, in accordance with some embodimentsof the present specification. Referring again to FIGS. 28A, 28J and 28K,the handle 2802 is coupled to the proximal end of the elongated member2805 having a first shaft or tube 2830, a second shaft or tube 2825, athird shaft or tube 2827, and a fourth shaft or tube 2816, that areconcentrically positioned relative to each other. In an embodiment, thefirst tube 2830 is concentrically positioned around the second tube2825, the second tube 2825 is concentrically positioned around the thirdtube 2827, and the third tube 2827 is concentrically positioned aroundthe fourth tube 2816.

As shown in FIG. 28B, the proximal element 2806 has a proximal end 2860and a distal end 2862. The distal end 2862 of the proximal element 2806is fixedly attached to the second tube 2825 at a point 2828, while theproximal end 2860 is fixedly attached to the first tube 2830 at a point2829. Similarly, the distal element 2807 has a proximal end 2856 and adistal end 2858. As shown, the distal end 2858 is fixedly connected onthe fourth tube 2816, while the proximal end 2856 is fixedly connectedto a point 2815 on the third tube 2827.

As shown, the handle 2802 includes first, second and third physicallymanipulable interfaces such as, for example sliders 2814, 2818 and 2820.Each of a first hub 2802 k, second hub 2804 k, third hub 2806 k, andfourth hub 2808 k enable respective first, second, third and fourthtubes 2830, 2825, 2827, 2816 to be coupled to the handle 2802. A fifthhub 2810 k is stationary to the handle 2802, is bonded to a PEEK(Polyether ether ketone) tube that goes around all the tubes 2830, 2825,2827, 2816, and extends a predefined length distally from a proximal end2830 k of the handle 2802 in order to provide kink resistance or act asa strain relief to prevent kinks and add stiffness at proximal ends ofthe tubes 2830, 2825, 2827, 2816 as the exit the proximal end 2830 k ofthe handle 2802.

In an embodiment, the first slider 2814 is coupled to the fourth tube2816 such that a sliding movement of the first slider 2814 (along alength of the handle 2802) causes the fourth tube 2816 to move axiallywhile the first, second and third tubes 2830, 2825, 2827 remainstationary thereby causing the distal element 2807 to expand orcontract. In some embodiments, sliding the first slider 2814 distally(towards the tip portion 2804) causes the fourth tube 2816 and thereforethe distal end 2858 to move proximally causing the distal element 2807to expand whereas sliding the first slider 2814 proximally (away fromthe tip portion 2804) causes the fourth tube 2816 and therefore thedistal end 2858 to move distally causing the distal element 2807 tocompress or contract. Thus, the movement of the first slider 2814 causesthe fourth tube 2816 to move relative to the third tube 2827. Inalternate embodiments, however, the first slider 2814 may be configuredto move the third tube 2827 relative to the fourth tube 2816.

The second slider 2818 is coupled to the first tube 2830 such that asliding movement of the second slider 2818 (along the length of thehandle 2802) causes the first tube 2830 to move axially while thesecond, third and fourth tubes 2825, 2827, 2816 remain stationarythereby causing the proximal element 2806 to expand or contract. In someembodiments, sliding the second slider 2818 distally (towards the tipportion 2804) causes the first tube 2830 and therefore the proximal end2860 to move distally thereby causing the proximal element 2806 toexpand whereas sliding the second slider 2818 proximally (away from thetip portion 2804) causes the first tube 2830 and therefore the proximalend 2860 to move proximally thereby causing the proximal element 2806 tocompress or contract. Thus, the movement of the second slider 2818causes the first tube 2830 to move relative to the second tube 2825. Inalternate embodiments, however, the second slider 2818 may be configuredto move the second tube 2825 relative to the first tube 2830.

The third slider 2820 is coupled to the first and second tubes 2830,2825 such that a sliding movement of the third slider 2820 (along thelength of the handle 2802) causes the first and second tubes 2830, 2825to move axially while the third and fourth tubes 2827, 2816 remainstationary thereby causing the proximal element 2806 to move relative tothe distal element 2807 (that remains stationary). In some embodiments,sliding the third slider 2820 distally (towards the tip portion 2804)causes the proximal element 2806 to move towards the distal element 2807whereas sliding the third slider 2820 proximally (away from the tipportion 2804) causes the proximal element 2806 to move away from thedistal element 2807.

In alternate embodiments, the third slider 2820 may be coupled to thethird and fourth tube 2827, 2816 such that a sliding movement of thethird slider 2820 (along the length of the handle 2802) causes the thirdand fourth tube 2827, 2816 to move axially while the first and secondtubes 2830, 2825 remain stationary thereby causing the distal element2807 to move relative to the proximal element 2806 (that remainsstationary). In some embodiments, sliding the third slider 2820 distally(towards the tip portion 2804) causes the distal element 2807 to moveaway from the proximal element 2806 whereas sliding the third slider2820 proximally (away from the tip portion 2804) causes the distalelement 2807 to move towards the proximal element 2806.

In some embodiments, by default, a spring loaded locking mechanism 2820k keeps the first and second hubs 2802 k, 2804 k locked/coupled to acarriage 2815 k. Sliding movement of the third slider 2820 moves thecarriage 2815 k causing the first and second tubes 2830, 2825 to bemoved in unison (relative to the third and fourth tubes 2827, 2816)resulting in the axial movement of the proximal element 2806 relative tothe distal element 2807 without affecting expansion/contraction of theproximal element 2806.

In some embodiments, the three sliders 2814, 2818, 2820 and the lockingmechanism utilize springs to stay locked in place with teeth on a rail,and must be pressed/depressed to release or unlock.

Depressing the second slider 2818 causes the locking mechanism 2820 k todecouple the first and second tubes 2830, 2825 from the carriage 2815 kand engage the second slider 2818 with the first tube 2830.Consequently, the sliding movement of the second slider 2818 causes thefirst tube 2830 to move axially thereby expanding or contracting theproximal element 2806. Once released, the locking mechanism 2820 k isactuated again and, therefore, the third slider 2820 can be used to moveboth first and second tubes 2830, 2825 and therefore the entire proximalelement 2806.

Thus, the second slider 2818 expands or contracts the proximal element2806 by moving the first tube 2830 while the second tube 2825 remainstationary. The second slider 2818 is configured to open or expand theproximal element 2806 incrementally and mechanically to one of aplurality of predefined geometric shapes, dimensions, sizes, diametersor volumes, each of which (other than the linear shape) is capable ofwithstanding a same or different applied pressure in the range of 0 to25 Newton. In some embodiments, the plurality of geometric shapesincludes at least two of linear, ellipsoid, spheroid, spherical or diskshape. In some embodiments, the second slider 2818 includes a pluralityof teeth on a rail that allows the proximal element 2806 to be opened orexpanded incrementally. As discussed earlier, the second slider 2818 isspring loaded, such that it needs to be depressed in order to move orslide the second slider 2818 to have a desired geometric shape,dimension, size, diameter or volume of the proximal element 2806. Inother words, the dimensional increments are built in and represented, insome embodiments, by corresponding iconography on the handle 2802 tovisually represent the plurality of predefined geometric shapes,dimensions, sizes, diameters or volumes of the proximal element 2806.Additionally, since a procedure using the retrieval device 2800, toremove an occlusion or unwanted material from a vessel lumen, istypically carried out under fluoroscopy, the physician can see theinternal diameter of the vessel lumen, feel the tactile feedback(generated due to the second slider 2818 having the plurality of teethon the rail that allows the proximal element 2806 to be opened orexpanded incrementally) versus the outer diameter of the expandedproximal element 2806 and have a visual reference.

In an embodiment, the fourth tube 2816 is configured to move in adirection opposite to a direction of movement of the first tube 2830. Inthe absence of the opposing movement of the first and second tubes 2830,2816, if the first slider 2814 is moved distally the fourth tube 2816will also move distally causing the distal element 2807 to contractwhile if the first slider 2814 is moved proximally then the fourth tube2816 will also move proximally causing the distal element 2807 toexpand. This movement of the first slider 2814 and the fourth tube 2816,however, is less intuitive to the user (since movement of the secondslider 2818 distally causes the proximal element 2806 to expand and viceversa). Therefore, a gear 2825 k reverses the direction of movement ofthe first slider 2814 in a 1:1 relation to the fourth hub 2808 k andtherefore the fourth tube 2816. Consequently, movement of the firstslider 2814 distally causes the fourth tube 2816 to move proximallycausing the distal element 2807 to expand while movement of the firstslider 2814 proximally causes the fourth tube 2816 to move distallycausing the distal element 2807 to contract.

Thus, the first slider 2814 expands or contracts the distal element 2807by moving the fourth tube 2816 while the first, second and third tubes2830, 2825, 2827 remain stationary. The first slider 2814 is configuredto open or expand the distal element 2807 incrementally and mechanicallyto one of a plurality of predefined geometric shapes, dimensions, sizes,diameters or volumes, each of which (other than the linear shape) iscapable of withstanding a same or different applied pressure in therange of 0 to 25 Newton. In some embodiments, the first slider 2814includes a plurality of teeth on a rail that allows the distal element2807 to be opened or expanded incrementally. In some embodiments, thefirst slider 2814 is spring loaded, such that it needs to be depressedin order to move or slide the first slider 2814 to have a desiredgeometric shape, dimension, size, diameter or volume of the distalelement 2807. In other words, the dimensional increments are built inand represented, in some embodiments, by corresponding iconography onthe handle 2802 to visually represent the plurality of predefinedgeometric shapes, dimensions, sizes, diameters or volumes of the distalelement 2807. Additionally, since a procedure using the retrieval device2800, to remove an occlusion or unwanted material from a vessel lumen,is typically carried out under fluoroscopy, the physician can see theinternal diameter of the vessel lumen, feel the tactile feedback(generated due to the first slider 2814 having the plurality of teeththat allows the distal element 2807 to be opened or expandedincrementally) versus the outer diameter of the expanded distal element2807 and have a visual reference.

Lock and Key System

As shown in a first view 2805 m of FIG. 28M, the retrieval device 2800is provided to the user (for example, upon purchase), with the handle2802 locked or inactivated, which can only be activated or unlocked uponusing an associated key 2804 m. In some embodiments, a pin 2806 m isplaced in the handle 2802, during assembly, such that the pin 2806 mpasses through the first, second and third sliders 2814, 2818, 2820thereby preventing the sliders from being actuated or moved. As shown ina second view 2810 m, in order to activate the handle 2802 (and,therefore, be able to actuate the sliders 2814, 2818, 2820), a key 2804m that is uniquely configured to pass through a first side of a keyhole2808 m (in the handle 2802) to cause the pre-placed pin 2806 m to bepushed out and protrude from a second side (opposite to the first side)of the keyhole 2808 m. The protruding pin 2806 m may then be grabbed bya user and pulled out by the user thereby unlocking, or allowing thesliders 2814, 2818, 2820 to freely move. In some embodiments, as shownin a third view 2815 m, the key 2804 m is designed such that a surface2822 m of the key 2804 m abuts or engages with a rib 2812 m in thehandle 2802 upon insertion through the first side of the keyhole 2808 m.Thus, the key 2804 m is characterized to one-way snap fit into thehandle 2802 so that it cannot be removed without breaking (since thesurface 2822 m abutting the rib 2812 provides substantial resistancewhen an attempt is made to pull the key 2804 m out of the first side ofthe keyhole 2808 m). It should be appreciated that the keyhole ispreferably uniquely designed such that handles may have one of aplurality of differently sized, shaped, or configured keyholes andtherefore require a similarly and complementarily designed key tosuccessfully pass through the keyhole and push out the pin.

Simultaneously Expandable and Contractable/Compressible Proximal andDistal Elements

FIG. 43 is a flowchart of a plurality of exemplary steps of a method4300 of using a retrieval device configured to remove an occlusion fromperipheral arterial vessels (and therefore treat peripheral arterialdisease), in accordance with an embodiment of the present specification.In accordance with some embodiments, the method 4300 enables removingthe occlusion from a lumen having an internal diameter ranging from 1 mmto 14 mm. In some embodiments, the method 4300 enables removing theocclusion from a lumen having an internal diameter less than 3 mm, andeven those less than 1 mm, wherein the lumen is one of, but not limitedto, biliary ducts, fistula declotting, brain blood vessels, upper andlower extremities, ureter, appendicular artery and peripheral arterialvessels (particularly in the hands, arms, forearms, thighs, legs andfeet).

For the method 4300, a retrieval device of the present specification,such as, for example, the device 2800, is configured or adapted forperforming thrombectomy procedures in biliary ducts, fistula declotting,hepatic bile ducts, brain blood vessels, upper and lower extremities,ureter, appendicular artery and peripheral arterial vessels(particularly in the hands, arms, forearms, thighs, legs and feet) inorder to treat peripheral arterial disease (PAD) and thromboembolicprocesses related to all arterial and hematologic pathologies. In suchembodiments of the retrieval device, the handle 2802 is coupled to aproximal end of the elongated member 2805 through at least onetelescoping tube, wherein a distal end of the elongated member 2805 hasthe tip portion 2804 mounted with proximal and distal elements 2806,2807. In some embodiments, the handle 2802 may include a physicallymanipulable interface such as, for example, a knob, slider or buttonthat is used to expand/open and contract/close both the proximal anddistal elements 2806, 2807 simultaneously. In some embodiments, adistance between the proximal and distal elements 2806, 2807 ispredefined/fixed and ranges from 2 cm to 6 cm. The physicallymanipulable interface such as a slider has a plurality of teeth on arail to enable the proximal and distal elements 2806, 2807 to expand oropen incrementally to a plurality of shapes, dimensions, sizes, volumesor outer diameters. In some embodiments, the proximal and distalelements 2806, 2807 may be expanded to shapes, dimensions, sizes,volumes or outer diameters corresponding to up to 20 increments. In someembodiments, the proximal and distal elements 2806, 2807 may be expandedto shapes, dimensions, sizes, volumes or outer diameters on a continuousbasis without set increments. In some embodiments, each of the pluralityof shapes, dimensions, sizes, volumes or outer diameters of the proximaland distal elements 2806, 2807 is capable of withstanding a same appliedpressure in the range of 0 to 25 Newton. Alternatively, in someembodiments, each of the plurality of shapes, dimensions, sizes, volumesor outer diameters of the proximal and distal elements 2806, 2807 iscapable of withstanding different applied pressure in the range of 0 to25 Newton.

The dimensional increments, for simultaneously expanding the proximaland distal elements 2806, 2807 are built in and represented, in someembodiments, by corresponding iconography on the handle 2802 to visuallyrepresent the plurality of predefined geometric shapes, dimensions,sizes, diameters or volumes of the proximal and distal elements 2806,2807. Additionally, since a procedure using the retrieval device, toremove an occlusion or unwanted material from a vessel lumen, istypically carried out under fluoroscopy, the physician can see theinternal diameter of the vessel lumen, feel the tactile feedback(generated due to the slider having the plurality of teeth on the rail)versus the outer diameter of the expanded proximal and distal elements2806, 2807 and have a visual reference. In some embodiments, theretrieval device with simultaneously expandable andcontractable/compressible proximal and distal element 2806, 2807 isconfigured to use a guidewire having a diameter of 0.014 in or 0.018 in,an aspiration catheter 2835 of 7 to 8 Fr and having a length of 135 cm,and an elongated member 2805 of 5 Fr having a length of 145 cm. In someembodiments, in a fully expanded state, a diameter of each of theproximal and distal elements ranges from 5 mm to 30 mm, preferably 10 mmto 25 mm, and more preferably 10 mm to 20 mm.

Optionally, in some embodiments, the handle 2802 may include anotherphysically manipulable interface such as, for example, a knob, slider orbutton that is used to axially move the proximal and distal element2806, 2807 together.

For use during the procedure, in some embodiments, a tip portion of theretrieval device (with proximal and distal elements that can be expandedand contracted simultaneously) is placed into a delivery catheter andthereafter the delivery catheter is inserted into the aspirationcatheter, and follows through to a valve hub, so that at least the tipportion projects distally from a distal end of the aspiration catheter.

Referring now to FIG. 43, in an embodiment, at step 4302, in order toretrieve an occlusion from the lumen of a patient, a guidewire isadvanced through the lumen of the patient and positioned through theocclusion. In some embodiments, the guidewire has a diameter of 0.014 inor 0.018 in. At step 4304, the aspiration catheter is advanced over theguidewire such that a distal end of the aspiration catheter ispositioned at or proximate the occlusion. At step 4306, the deliverycatheter is advanced through the aspiration catheter such that a distalend of the delivery catheter lies proximate the distal end of theaspiration catheter.

At step 4308, the retrieval device (with proximal and distal elementsthat can be expanded and contracted simultaneously) is positioned nearthe occlusion with the distal element mounted on the tip portion of theretrieval device is positioned within or all the way through and beyondthe occlusion. In some embodiments, this ensures that the proximal anddistal elements, in compressed or non-expanded state, are positionedwithin the occlusion.

At step 4310, the proximal and distal elements, positioned within theocclusion, are mechanically expanded, simultaneously, to desireddiameters (and therefore, to corresponding shapes and to exertcorresponding radial forces). In an embodiment, a slider on a handle ofthe retrieval device is actuated to cause the wire mesh structures ofthe proximal and distal elements to expand out concurrently. In someembodiments, upon expansion, the proximal and distal elements areconfigured to resist compression from an applied force in a range of 0to 25 Newtons.

At step 4312, the proximal and distal elements are moved axially (in oneor more fore and aft motions) to dislodge and scrape/curettage theocclusion. In some embodiments, the occlusion can also be trapped intothe mesh lattices of the proximal and distal elements.

In some embodiments, the handle is moved fore and aft to cause the tipportion and therefore the proximal and distal elements to be moved foreand aft in order to dislodge and curettage the occlusion. In anotherembodiment, another slider provided on the handle is actuated to axiallymove the proximal and distal elements together relative to the tipportion. In some embodiments, the proximal and distal elements areconfigured to be moved axially in a range from 1 mm to 8 cm andpreferably at least 6 cm.

At step 4314, the dislodged and scraped occlusion is removed oraspirated by applying a negative pressure through the aspirationcatheter. In some embodiments, the fore and aft movement of the proximaland distal elements further directs the dislodged and scraped occlusiontowards the aspiration catheter.

At step 4316, the proximal and distal elements are collapsed orcompressed simultaneously. In some embodiments, the slider is actuatedto cause the proximal and distal elements to collapse or compress.Finally, at step 4318, the proximal and distal elements, in collapsed orcompressed state, are retracted and removed from the lumen of thepatient.

FIG. 29A illustrates a retrieval device 2900 with unexpanded proximaland distal elements, in accordance with an embodiment of the presentspecification. FIG. 29B illustrates the retrieval device 2900 withexpanded proximal and distal elements, in accordance with an embodimentof the present specification. FIG. 29C illustrates the retrieval device2900 with a plurality of telescoping tubes maneuvered to reduce adistance between the proximal and distal elements, in accordance with anembodiment of the present specification. Referring to FIGS. 29A, 29B and29C, in some embodiments, the distal element 2902 and the proximalelement 2904 are affixed to a set of first, second, third and fourthtelescoping tubes 2906, 2908, 2910 and 2912, wherein the first tube 2906is shown extending beyond a delivery catheter 2914.

In embodiments, the telescoping tubes 2906, 2908, 2910 and 2912 arecapable of being retracted or expanded axially relative to each other,thereby decreasing or increasing, respectively, a distance between thedistal element 2902 and the proximal element 2904. The retraction andexpansion of the telescoping tubes 2906, 2908, 2910 and 2912 as well asthe expansion and contraction of the distal and proximal elements 2902,2904, in an embodiment, is carried out by means of a handle of theretrieval device 2900. In embodiments, an axial compression betweenrespective proximal and distal ends of the of the distal and proximalelements 2902, 2904 causes the elements 2902, 2904 to expand radiallyabout a longitudinal axis and obtain a diameter greater than a diameterin an unexpanded state.

FIG. 29A shows the distal and proximal elements 2902, 2904 completelyunexpanded, while the elements are shown fully expanded in FIGS. 29B and29C. As shown in FIG. 29B, by using a handle (not shown in FIG. 29), thefirst tube 2906 is extended, the second tube 2908 is retracted, thethird tube 2910 is extended and the fourth tube 2912 is retractedthereby increasing a distance between the distal and proximal elements2902, 2904. As shown in FIG. 29C, the first tube 2906 is extendedfurther while the third tube 2910 is retracted to decrease the distancebetween the distal and proximal elements 2902, 2904.

In some embodiments, to remove an occlusion, the distal element 2902 ispositioned within, or all the way through, the occlusion so that thedistal element 2902 is held fixed in a position within or beyond adistal end of the occlusion while the proximal element 2904 precedes aproximal end of the occlusion. Subsequently, the proximal element 2904is moved back and forth axially along a longitudinal axis to dislodgeand trap the occlusion between the distal and proximal elements 2902,2904. Thus, by maneuvering the handle, the distance between the distaland proximal elements 2902, 2904 can be increased/decreased to dislodgethe occlusion and trap the occlusion between the distal and proximalelements 2902, 2904. This is described in detail in subsequentparagraphs with reference to FIGS. 30A-30H.

Referring back to FIGS. 28A through 28J, in some embodiments, theretrieval device 2800 is configured to be maneuvered using the handleportion 2802 such that the size, shape and relative position of both theproximal and distal elements 2806, 2807 as well as the radial forcebeing applied by both the proximal and distal elements 2806, 2807 may beadjusted.

FIG. 30A illustrates a retrieval device 3000, in accordance with anembodiment of the present specification. FIG. 30B illustrates anexpanded handle portion of the retrieval device 3000, in accordance withan embodiment of the present specification. FIG. 30C illustrates acompressed handle portion of the retrieval device 3000, in accordancewith an embodiment of the present specification. Referring to FIGS. 30A,30B and 30C, the device 3000 comprises a handle portion 3002 and a tipportion 3004. The tip portion has a proximal end 3050 and a distal end3052. During operation of the device 3000, the tip portion 3004 isinserted into a body lumen for removing an occlusion while the handleportion 3002 remains in an operator/user's hands to maneuver theinsertion of the tip portion 3004 in a desired position in the bodylumen. During insertion of the device 3000 into the body lumen, thedistal end 3052 of the tip portion 3004 enters the body first and isplaced within, beyond or in close proximity of the occlusion within ablood vessel of the body by using the handle 3002.

The tip portion 3004 comprises a distal element or body 3007, which inan embodiment, is a mechanically expandable, rigid anchor fixedlyattached to the distal end 3052 of the tip portion 3004, and a proximalelement or body 3006, which in an embodiment is a pusher ball that isslidably mounted on the proximal end 3050 of the tip portion 3004. Thetip portion 3004 is at least partially covered with a sheath 3005 whichmay be retracted exposing at least the distal element 3007 and proximalelement 3006 when the device 3000 is inserted and maneuvered within avasculature of a person, by using the handle portion 3002.

In some embodiments, the distal element 3007 can take the form of acylinder, stent, chalice cup, umbrella, concave structure, half-sphere,sphere, windsock, dumbbell, star, polygon, lever, or any other suitableshape configured for holding an occlusion and aiding retrieval of theocclusion. In some embodiments, the tip portion 3004 comprises flexibleelements or tubes 3008 that extend all the way back to the handleportion 3002 and can be maneuvered together to enable an operator/doctorto expand or contract the distal and proximal elements 3007, 3006 aswell as slide the proximal element 3006 (towards or away from the distalelement 3007) for removing the occlusion. In an embodiment, the flexibleelements 3008 comprise four flexible telescoping tubes as describedearlier with reference to FIGS. 29A-29C.

Referring to FIGS. 30A, 30B and 30C, in embodiments, the proximalelement 3006 is enabled to move relative to the distal element 3007 forremoval of the occlusion. The handle portion 3002 comprises a first knob3010 configured to actuate the proximal element 3006, a second knob 3012configured as a ‘press and hold’ button, a third knob 3014 configured toactuate the distal element 3007 and flexible elements 3008 which extendup to the tip portion 3004. The flexible elements 3008 enable theproximal element 3006 and the distal element 3007 to move relative toeach other for removal of the occlusion as is described with referenceto FIGS. 29A, 29B and 29C.

In some embodiments, the distal element 3007 is expanded to a pluralityof intermediate diameters (and up to a maximum permissible diameter) byrotating the third knob 3014 in an anticlockwise direction. Rotating thethird knob 3014 in a clockwise direction contracts the distal element3007 back to the plurality of intermediate diameters and eventually to anon-expanded/collapsed state from the expanded state. In someembodiments, the proximal element 3006 is expanded to a plurality ofintermediate diameters (and up to a maximum permissible diameter) byrotating the first knob 3010 in an anticlockwise direction. Rotating thefirst knob 3010 in a clockwise direction contracts the proximal element3006 back to the plurality of intermediate diameters and eventually to anon-expanded/collapsed state from the expanded state. FIG. 30Dillustrates fully expanded proximal and distal elements 3006, 3007, inaccordance with an embodiment of the present specification. FIG. 30Eillustrates fully collapsed proximal and distal elements 3006, 3007, inaccordance with an embodiment of the present specification.

A distance between the proximal and distal elements 3006, 3007 may bedecreased by pressing the second knob 3012 and moving the first knob3010 towards the tip portion 3004. As the distance between the secondknob 3012 and the first knob 3010 increases, the distance between theproximal and distal elements 3006, 3007 decreases. FIGS. 30B and 30Fillustrate an expanded handle portion 3002 wherein the first knob 3010is moved away from the second knob 3012, while FIGS. 30C and 30Hillustrate a compressed handle portion 3002 wherein the first knob 3010is moved towards the second knob 3012 to lie proximate to the secondknob 3012. As the distance between the second knob 3012 and the firstknob 3010 decreases, the distance between the proximal and distalelements 3006, 3007 increases. FIG. 30G illustrates a compressed orreduced distance between the proximal and distal elements 3006, 3007 asa result of the expanded handle portion shown in FIGS. 30B and 30F. Auser may use the second knob 3012 along with the first knob 3010 tocause a relative movement between the proximal and distal elements 3006,3007 for dislodging an occlusion, and causing the occlusion to be lodgedbetween the proximal and distal elements 3006, 3007 for removal from apatient's body.

In some embodiments, a protective bag covers a tip portion of aretrieval device of the present specification. The protective bag may beremoved from the tip portion and re-draped over the tip portion asneeded. FIGS. 33A, 33B and 33C show a tip portion 3304 of a retrievaldevice (such as, the retrieval device 2800, 2900 or 3000). As describedearlier in the specification, the tip portion 3304 has four telescopingtubes (such as the tubes 2906, 2908, 2910 and 2912 of FIG. 29A) that, insome embodiments, have respective lumens.

As shown in FIG. 33A, when proximal and distal elements 3306, 3308 arein fully collapsed or contracted states, the tip portion 3304 includingthe proximal and distal elements 3306, 3308, is enclosed or covered by abag 3305. A first tether 3310, such as a wire, is attached to aninternal surface of the bag 3305 at its distal end 3314. In someembodiments, the first tether 3310 extends from the distal end 3314 ofthe bag 3305 through the respective lumens of the four telescoping tubesand up to a handle (such as, the handle 2802 of FIG. 28A) of theretrieval device. Second and third tethers 3312 a, 3312 b (which mayalso be wires) are attached to proximal ends 3313 a, 3313 b of the bag3305. In some embodiments, the second and third tethers 3312 a, 3312 bextend from the proximal ends 3313 a, 3313 b of the bag 3305 to thehandle of the retrieval device.

As shown in FIG. 33B, once the tip portion 3304 is positioned forremoval of an occlusion, a force is applied proximally on the firsttether 3310 causing the first tether 3310 to be pulled towards thehandle and away from the tip portion 3304 thereby causing the bag 3305to collapse and be retracted into the lumen of at least one of the fourtelescoping tubes. This results in exposing the proximal and distalelements 3306, 3308 that can now be expanded.

Referring now to FIG. 33C, once the occlusion is dislodged and trappedbetween the proximal and distal elements 3306, 3308, the proximal anddistal elements 3306, 3308 are fully collapsed or contracted.Subsequently, a force is applied proximally on the second and thirdtethers 3312 a, 3312 b causing them to be pulled towards the handle andaway from the tip portion 3304 thereby causing the collapsed bag 3305 ofFIG. 33B to be pulled out of the lumen and be wrapped or covered overthe tip portion 3304 again. Thereafter, the tip portion 3304 may beremoved or pulled out along with the occlusion trapped between theproximal and distal elements 3306, 3308.

It should be appreciated that the bag 3305 in FIGS. 33A and 33C enablesthe tip portion 3304 to be atraumatic during insertion and retrieval ofthe tip portion 3304 into a vascular lumen or a non-vascular structureof a patient. Additionally, the bag in FIG. 33C encompasses theocclusion, trapped between the proximal and distal elements 3306, 3308,and acts as a further measure of ensuring that the trapped occlusion isnot lost during removal of the tip portion 3304 from the body of thepatient.

In some embodiments, structurally, leading portions of the proximal anddistal elements are different from trailing portions of the proximal anddistal elements. FIG. 34A shows a tip portion 3404 of a retrieval device(such as, the retrieval device 2800, 2900 or 3000) having proximal anddistal elements 3406, 3408 fully collapsed or in unexpanded state, whileFIG. 34B shows the tip portion 3404 with the proximal and distalelements 3406, 3408 fully expanded, in accordance with some embodimentsof the present specification.

The proximal element 3406 has a leading portion 3406 a and a trailingportion 3406 b. Similarly, the distal element 3407 has a leading portion3408 a and a trailing portion 3408 b. In some embodiments, the leadingportions 3406 a, 3408 a are solid (such as, for example, made of abiocompatible fabric) while the trailing portions 3406 b, 3408 b arewire meshes having a plurality of cells. This causes the leadingportions 3406 a, 3408 a to be more rigid, stiff or firm compared to thetrailing portions 3406 b, 3408 b. In some embodiments, the leadingportions 3406 a, 3408 a as well as the trailing portions 3406 b, 3408 bare wire meshes. However, the leading portions 3406 a, 3408 a have aplurality of cells of a first size while the trailing portions 3406 b,3408 b have a plurality of cells of a second size. In some embodiments,the first size is smaller compared to the second size causing theleading portions 3406 a, 3408 a to be more rigid, stiff or firm comparedto the trailing portions 3406 b, 3408 b.

In various embodiments, the leading and trailing portions may or may notbe substantially halves of the respective proximal and distal elements.It should be appreciated that the more rigid, stiff or firm leadingportions 3406 a, 3408 a enable the tip portion 3404 to be effectivelyslid through an occlusion, bareback.

FIG. 35 shows a tip portion 3504 of a retrieval device (such as, theretrieval device 2800, 2900 or 3000) with proximal and distal elements3506, 3508 in fully collapsed or unexpanded state, in accordance withsome embodiments of the present specification. A tether 3510, such as awire, is coupled or attached to trailing or proximal ends 3506′, 3508′of the respective proximal and distal elements 3506, 3508. The tether3510 extends from the trailing or proximal ends 3506′, 3508′ all the wayto a handle of the retrieval device. While advancing the tip portion3500, bareback, in a patient's body the tether 3510 is pulled proximallytowards the handle and thereby kept taut. This prevents the proximal anddistal elements 3506, 3508 from expanding inadvertently thereby holdingthem retracted and flat.

FIG. 31A is a flowchart of a plurality of exemplary steps of treatingpulmonary embolism (PE) by using any of the retrieval devices 2800, 2900or 3000, in accordance with an embodiment of the present specification.In some embodiments, treatment of PE involves removing an occlusion froma lumen of a patient's pulmonary vessel.

At step 3102 a, a guidewire is advanced through the lumen of the patientand positioned through the occlusion. At step 3104 a, an aspirationcatheter is advanced over the guidewire such that a distal end of theaspiration catheter is positioned at or proximate the occlusion. At step3106 a, a delivery catheter is advanced through the aspiration cathetersuch that a distal end of the delivery catheter lies proximate thedistal end of the aspiration catheter. At step 3108 a, a retrievaldevice is deployed through the delivery catheter so that a distalelement mounted on a tip portion of the retrieval device is positionedwithin or all the way through and beyond the occlusion.

At step 3110 a, the distal element is mechanically expanded to a desireddiameter using a first slider on a handle of the retrieval device. Insome embodiments, the distal element is a mechanically expandable andrigid anchor fixedly attached proximate a distal end of the tip portion.

At step 3112 a, a proximal element (also mounted on the tip portion) ismechanically expanded to a desired diameter using a second slider on thehandle of the retrieval device.

At step 3114 a, the proximal element is moved axially (in one or moreback and forth motions) along the tip portion to dislodge the occlusion(and curettage the vessel). In some embodiments, the axial fore and aftmovement of the proximal element results in capturing at least a portionof the occlusion between the proximal and distal elements. The proximalelement is moved using a third slider on the handle of the retrievaldevice. In some embodiments, as shown in FIG. 28I, an occlusion 2880 canbe trapped into the mesh lattices of the distal element 2807 and theproximal element 2806 of the retrieval device 2800, for example.

In various embodiments, the anchoring of the rigid distal elementproximate the distal end of the tip portion followed by a mechanicalexpansion of the distal element using the first slider (as opposed to aNitinol temperature-based expansion) provides the distal element arequired minimum degree of rigidity to anchor in place within the lumenand/or preferably wedged into the occlusion. Persons of ordinary skillin the art would appreciate that if the distal element is not rigid andnot solidly anchored, the retrieval device may not have sufficientleverage to dislodge the occlusion.

In some embodiments, the anchoring of the distal element to the tipportion and the occlusion (in embodiment where the distal element ispositioned within the occlusion) while attaining a required degree ofrigidity locks the distal element in a desired location with respect tothe occlusion, and allows the proximal element to move back and forthlongitudinally with respect to the distal element to dislodge theocclusion.

In an embodiment, the distal element is positioned and expanded withinthe occlusion (like a fishing hook), and in another embodiment thedistal element is positioned and expanded distal to (or beyond) theocclusion. In an embodiment the proximal element is expanded proximal to(prior to) or within the occlusion, such that the proximal element canbe moved all the way into the expanded (concave or cup-shaped) distalelement to generate a vice-like grip and trap the occlusion between theproximal and distal elements. In some embodiments, once the occlusion istrapped between the proximal and distal elements, the distance betweenthe proximal element and the distal element may be reduced further suchthat the proximal element moves all the way into or proximate the distalelement.

At step 3116 a, aspiration is used to concurrently remove at least aportion of the occlusion. In some embodiments, aspiration is performedby applying negative pressure at a proximal end of the aspirationcatheter.

At step 3118 a, the proximal and distal elements are mechanicallycompressed/collapsed, pulled back and removed from the lumen.

In some embodiments, the portion of the occlusion captured between theproximal and distal elements is removed by pulling out the proximalelement, the portion of the occlusion and the distal element togetherfrom the lumen of the patient.

In some embodiments, a first portion of the occlusion captured betweenthe proximal and distal elements is removed by pulling out the proximalelement, the first portion of the occlusion and the distal element whilea remaining second portion is aspirated using an aspiration catheter. Invarious embodiments, the exact technique of removing the occlusionvaries depending upon factors such as, but not limited to, theanatomical location of the occlusion within the patient's body, and thecomplexity and density of the occlusion. However, in variousembodiments, removal of the occlusion involves some degree of moving theproximal element relative to the distal element to dislodge, trap andaspirate the occlusion.

FIG. 31B is a flowchart of a plurality of exemplary steps of treatingdeep vein thrombosis (DVT) by using any of the retrieval devices 2800,2900 or 3000, in accordance with an embodiment of the presentspecification. In some embodiments, treatment of DVT involves removingan occlusion from a lumen of a patient's deep vein/vessel.

At step 3102 b, a guidewire is advanced through the lumen of the patientand positioned through the occlusion. At step 3104 b, an aspirationcatheter is advanced over the guidewire such that a distal end of theaspiration catheter is positioned at or proximate the occlusion. At step3106 b, a delivery catheter is advanced through the aspiration cathetersuch that a distal end of the delivery catheter lies proximate thedistal end of the aspiration catheter. At step 3108 b, a retrievaldevice is deployed through the delivery catheter so that a distalelement mounted on a tip portion of the retrieval device is positionedwithin or all the way through and beyond the occlusion.

At step 3110 b, the distal element is mechanically expanded to a desireddiameter using a first slider on a handle of the retrieval device. Insome embodiments, the distal element is a mechanically expandable andrigid anchor fixedly attached proximate a distal end of the tip portion.

At step 3112 b, a proximal element (also mounted on the tip portion) ismechanically expanded to a desired diameter using a second slider on thehandle of the retrieval device.

At step 3114 b, the proximal element is moved axially (in one or moreback and forth motions) along the tip portion to dislodge the occlusion(and curettage the vessel). In some embodiments, the axial fore and aftmovement of the proximal element results in capturing at least a portionof the occlusion between the proximal and distal elements. The proximalelement is moved using a third slider on the handle of the retrievaldevice. In some embodiments, as shown in FIG. 28I, an occlusion 2880 canbe trapped into the mesh lattices of the distal element 2807 and theproximal element 2806 of the retrieval device 2800, for example.

In various embodiments, the anchoring of the rigid distal elementproximate the distal end of the tip portion followed by a mechanicalexpansion of the distal element using the first slider (as opposed to aNitinol temperature-based expansion) provides the distal element arequired minimum degree of rigidity to anchor in place within the lumenand/or preferably wedged into the occlusion. Persons of ordinary skillin the art would appreciate that if the distal element is not rigid andnot solidly anchored, the retrieval device may not have sufficientleverage to dislodge the occlusion.

In some embodiments, the anchoring of the distal element to the tipportion and the occlusion (in embodiment where the distal element ispositioned within the occlusion) while attaining a required degree ofrigidity locks the distal element in a desired location with respect tothe occlusion, and allows the proximal element to move back and forthlongitudinally with respect to the distal element to dislodge theocclusion.

In an embodiment, the distal element is positioned and expanded withinthe occlusion (like a fishing hook), and in another embodiment thedistal element is positioned and expanded distal to (or beyond) theocclusion. In an embodiment the proximal element is expanded proximal to(prior to) or within the occlusion, such that the proximal element canbe moved all the way into the expanded (concave or cup-shaped) distalelement to generate a vice-like grip and trap the occlusion between theproximal and distal elements. In some embodiments, once the occlusion istrapped between the proximal and distal elements, the distance betweenthe proximal element and the distal element may be reduced further suchthat the proximal element moves all the way into or proximate the distalelement.

At step 3116 b, aspiration is used to concurrently remove at least aportion of the occlusion. In some embodiments, aspiration is performedby applying negative pressure at a proximal end of the aspirationcatheter.

At step 3118 b, the proximal and distal elements are mechanicallycompressed/collapsed, pulled back and removed from the lumen.

In some embodiments, the portion of the occlusion captured between theproximal and distal elements is removed by pulling out the proximalelement, the portion of the occlusion and the distal element togetherfrom the lumen of the patient.

In some embodiments, a first portion of the occlusion captured betweenthe proximal and distal elements is removed by pulling out the proximalelement, the first portion of the occlusion and the distal element whilea remaining second portion is aspirated using an aspiration catheter. Invarious embodiments, the exact technique of removing the occlusionvaries depending upon factors such as, but not limited to, theanatomical location of the occlusion within the patient's body, and thecomplexity and density of the occlusion. However, in variousembodiments, removal of the occlusion involves some degree of moving theproximal element relative to the distal element to dislodge, trap andaspirate the occlusion.

FIG. 32A illustrates a human pulmonary artery 3200 with a blood clot3202 on a left side of the artery 3200. FIG. 32B illustrates a retrievaldevice 3204 of the present specification, inserted into the pulmonaryartery 3200 with a tip portion 3206 of the retrieval device 3204positioned within the clot 3202. The tip portion has proximal and distalelements 3207, 3208. FIG. 32C illustrates an expanded distal element3208 holding the blood clot 3202, which can be removed from thepulmonary artery 3200 by withdrawing the retrieval device 3204.

In various embodiments, the retrieval device 3204 is one of devices2800, 2900 or 3000 of the present specification.

As shown in FIG. 32B, the tip portion 3206 of the device 3204 is lodgedinto the blood clot 3202. Next (as also described earlier in thespecification with respect to FIGS. 28A-28G and 30A-30H), proximal anddistal elements 3207, 3208 are expanded and the blood clot 3202 istrapped in the expanded distal element 3208, which takes a concave shapeupon expansion, by moving the proximal element 3207 relative to thedistal element 3208. In an embodiment, the distal element 3208 does notexpand fully to form a cup like structure, instead the distal element3208 expands until an outer wall of the expanded distal element 3208touches internal walls of the artery 3200.

In other words, a distal element expands to a diameter equal to aninternal diameter of a vein/artery/lumen into which a tip portion of aretrieval device is inserted and creates a radial force to macerate anocclusion which can then be removed by pulling out the retrieval devicefrom the vasculature.

FIGS. 37A through 37F illustrate various stages in a procedure ofremoving a clot 3702 in a nerve vessel 3705 using a retrieval device3700, in accordance with some embodiments of the present specification.In some embodiments, a tip portion 3704 of the retrieval device 3700includes proximal and distal elements 3710, 3712 that are self-expandingelements of Nitinol wire mesh or of woven Nitinol fabric. The proximalelement 3710 is the only component of the device 3700 that is actuated(using a knob on a handle of the device 3700) to move axially in orderto dislodge and mobilize the clot 3702. The distal element 3712 isfixedly mounted on the tip portion 3704 and provides embolic protection.In various embodiments, the proximal and distal elements 3710, 3712 arethree dimensional geometric shapes and may be approximately spherical,elliptical or cylindrical in shape when in fully expanded states.

At step 3750 a (FIG. 37A), the tip portion 3704 is introduced into thenerve vessel 3705 and the proximal and distal elements 3710, 3712extended from, for example, an aspiration catheter 3715 (or from adelivery catheter or sheath) and positioned so that the clot 3702 liesbetween the proximal and distal elements 3710, 3712. The proximalelement 3710 is moved axially to dislodge and mobilize the clot 3702. Insome embodiments, the proximal and distal elements 3710, 3712 areflexible to self-expand and contract in accordance with a diameter of alumen of the nerve vessel 3705. As shown in FIG. 37A, the distal element3712 provides embolic protection.

At step 3750 b (FIG. 37B), the proximal element 3710 is begun to beretracted into the aspiration catheter 3715 and is fully retracted intothe aspiration catheter 3715 at step 3750 c (FIG. 37C). As shown inFIGS. 37B and 37C, the proximal element 3710 self-contracts into theaspiration catheter 3715.

At step 3750 d (FIG. 37D), the dislodged clot 3702 is aspirated throughthe aspiration catheter 3715. Next, at step 3750 e (FIG. 37E), the tipportion 3704 is begun to be retracted back into the aspiration catheter3715 while the distal element 3712 self-contracts into the aspirationcatheter 3715. Finally, at step 3750 f (FIG. 37F), the tip portion 3704is fully retracted into the aspiration catheter 3715 and the device 3700is removed, along with the clot 3702 from the nerve vessel 3705.

FIG. 38 is a flowchart of a plurality of exemplary steps of retrievingan occlusion by using the retrieval device 3700 (of FIGS. 37A through37F), in accordance with some embodiments of the present specification.In an embodiment, in order to retrieve an occlusion from a lumen of apatient's nerve vessel, at step 3802, an aspiration catheter (or adelivery catheter or a sheath) of the retrieval device is positionednear the occlusion with a distal end of a tip portion of the retrievaldevice, protruding from the aspiration catheter (or delivery catheter orsheath), being positioned within or all the way through and beyond theocclusion. In an embodiment, a handle of the retrieval device is used tomaneuver and position the tip portion.

At step 3804, as the tip portion is positioned, a distal element, whichis fixedly attached to the distal end of the tip, and a proximalelement, slidably coupled to a proximal end of the tip portion,self-expand to respective first and second diameters. In someembodiments, the first and second diameters are same and in accordancewith a diameter of the lumen of the nerve vessel. In some embodiments,the first and second diameters are dissimilar.

In an embodiment, the distal element is positioned within the occlusion,and in another embodiment the distal element is positioned distal to (orbeyond) the occlusion. In an embodiment the proximal element ispositioned proximal to (prior to) or within the occlusion, such that theproximal element can be moved all the way up to the expanded distalelement to generate a vice-like grip and trap the occlusion between theproximal and distal elements. In some embodiments, once the occlusion istrapped between the proximal and distal elements, the distance betweenthe proximal element and the distal element may be reduced further suchthat the proximal element moves proximate the distal element.

At step 3806 the proximal element is moved axially (in one or more toand fro motions) along the tip portion to dislodge the occlusion in amanner that captures the occlusion between the proximal and distalelements.

At step 3808, in some embodiments, the occlusion captured between theproximal and distal elements is removed by retracting the proximalelement, aspirating the occlusion and thereafter retracting the distalelement into the aspiration catheter. The distal and proximal elementsself-contract into the aspiration catheter as they are retracted. Inother words, first the proximal element is retracted into the aspirationcatheter, then the occlusion (dislodged and captured between the distaland proximal elements) is aspirated through the aspiration catheter andfinally the distal element is also retracted into the aspirationcatheter.

In some embodiments, a first portion of the occlusion captured betweenthe proximal and distal elements is removed by pulling out the proximalelement, the first portion of the occlusion and the distal element whilea remaining second portion is aspirated using the aspiration catheter.In various embodiments, the exact technique of step 3808 variesdepending upon factors such as, but not limited to, the anatomicallocation of the occlusion within the patient's body, and the complexityand density of the occlusion. However, in various embodiments, step 3808involves some degree of moving the proximal element relative to thedistal element to dislodge and trap the occlusion.

In some embodiments, a retrieval device of the present specification isconfigured to have at least one of the proximal and distal elements beformed of first and second braids respectively and positioned on a tipportion of the device. The first and second braids are coupled onto ashaft that is torqued. As the shaft is untorqued, each of the first andsecond braids expands and pulls together to form a football shape. Thus,in some embodiments, a centrifugal force applied to the shaft (via thehandle) causes the shaft to spin or rotate in order to untorque andexpand the first and second braids.

In some embodiments, a portion of the first or second braid is coveredso that as the covered braid expands, the cover acts as a funnel foraspiration or curettage of the clot material. In some embodiments, aproximal portion of the first or second braid is covered while thedistal portion is open or not covered. Since the open portion is distal,affected aspiration is directed, isolated or focused onto fluid/clotdistal to the tip portion.

It should be appreciated that in preferred embodiments a retrievaldevice of the present specification is characterized by a) a proximalelement and a distal element being able to expand or open as well ascontract or close independently, b) the proximal and distal elements notbeing self-expanding/self-contracting but rather only expand or contractmechanically by the application/removal of force, and c) the proximalelement being configured to move relative to the distal element orvice-versa. However, in less preferred embodiments, a retrieval deviceof the present specification is characterized by a) a single physicallymanipulable interface such as, for example, a knob, slider or buttonbeing configured to expand or contract the proximal and distal elementsconcurrently, b) the proximal and distal elements being configured topartially self-expand, and/or c) the proximal and distal elements beingconfigured to move axially together in a coordinated fashion.

Key Characteristics of a Retrieval Device

In various embodiments, a retrieval device (such as, the devices 2800,2900, 3000, 3304, 3504 and 3700) of the present specification isconfigured to have a plurality of characteristics, such as follows:

-   -   In some embodiments, the retrieval device includes proximal and        distal elements that are three dimensional (3D) geometric        shapes. In some embodiments, the proximal and distal elements        are independently expandable, compressible, and moveable        relative to each other yet mounted on a single delivery system.    -   In some embodiments, each geometric shape (proximal and distal        elements) can independently expand even while the other        geometric shape or element cannot expand, is blocked or is being        moved. The retrieval device enables active (controlled)        mechanical expansion of each of the proximal and distal elements        by the user.    -   In some embodiments, the retrieval device includes a handle        system at a proximal end, wherein the handle system includes        three sliders, levers, dials, or buttons that allow for the        independent expansion/contraction of the distal element,        independent expansion/contraction of the proximal element, and        independent axial movement of the proximal element relative to        the distal element.    -   In some embodiments, the handle includes a plurality of        gradations such as, for example, three gradations of low, medium        and high, five gradations ranging from low to high or eight        gradations ranging from low to high. Each gradation is        indicative of a corresponding predefined diameter of the        proximal and distal elements in expanded states. The three slide        buttons can be actuated to any one of the plurality of        gradations and then détente to that position.    -   In some embodiments, handle or axial force (that is, the pulling        or pushing force that comes into force due to actuation of each        of the three slide buttons) ranges from 0 to 20 Newtons and        generally up to 60 Newtons, preferably from 9 to 15 Newtons. In        other words, the handle or axial force is a force required to,        for example, pull on one of the shafts to expand the braid wires        of any of the proximal or distal elements. In embodiments,        therefore, the proximal and distal elements are capable of        delivering controlled radial force.    -   In some embodiments, the retrieval device enables one geometric        shape (that is, the proximal element) to move linearly fore and        aft while another tandem geometric shape (that is, the distal        element) remains in place. Thus, the proximal element is        configured to independently move forward and backward along a        wire/lumen even while the distal element cannot expand, is        blocked, is stationary or is being moved in a different        direction.    -   In some embodiments, the geometric shapes (proximal and distal        elements) can perform multiple passes without re-sheathing—that        is, position the elements, expand the elements, drag out embolic        material, flatten the elements, position the elements, expand        the elements, drag out embolic material and so on. Stated        differently, the retrieval device is capable of multiple        (thrombus related) extraction passes without the need to        re-sheath or reintroduce the device.    -   In some embodiments, a minimum distance between the proximal and        distal elements ranges from 0 to 5 mm and a maximum distance        between the proximal and distal elements 2806, 2807 ranges from        60 mm to 400 mm.    -   In some embodiments, the retrieval device enables an operator to        actively adjust the respective diameters of the individual        geometric shapes (proximal and distal elements) across a range        of diameters.    -   In some embodiments, each geometric shape (proximal and distal        elements) is configured to independently apply a radial force        preferably in a range of 10 Newtons to 14 Newtons. More        generally, each of the proximal and distal elements can be        mechanically expanded to allow for controlling an amount of        radial force applied ranging from 0 to 40 Newtons and, in some        embodiments, generally ranging from 0 to 25 Newtons. Therefore,        each element can be expanded to reach a radial force level and        maintain the element at the reached radial force level without        further action. It should be appreciated that force is a        function of a length of contact of each of the proximal and        distal elements with a vessel wall. For example, in a 5 mm        vessel, the length of contact of an element could be 0.9 inches        while in a 12 mm vessel, the length of contact of the element        could be 0.6 inches. However, the degree of radial force is not        likely the same across an entire length of contact (in fact, it        may be more at some portions and less in other portions of the        contact length). Therefore, “radial force” refers to an average        force applied along the length of contact and is not necessarily        equal along the entire length of contact.    -   In some embodiments, the retrieval device enables the operator        to actively adjust the exerted radial forces of the individual        geometric shapes (proximal and distal elements) across a range        of diameters and/or within a fixed diameter.    -   In some embodiments, the retrieval device enables each geometric        shape (proximal and distal elements) to be simultaneously and        independently adjusted with respect to size, shape, location and        radial force relative to the other.    -   In some embodiments, the retrieval device provides continuous        distal embolic protection (using the distal element) while        simultaneously engaging in remote proximal thrombectomy (using        the proximal element). The distal embolic protection is enabled        because the distal element opposes to the vessel wall and        contains pores ranging from 0.01 inches to 0.08 inches,        preferably 0.02 inches to 0.06 inches, encompassing a        cross-sectional area of a blood vessel and thereby substantially        blocking anything flowing out.    -   In some embodiments, the geometric shapes enable maceration of        embolic material to fit through an aspiration catheter.    -   In some embodiments, the retrieval device can utilize linear        travel and geometric shape apposition and compression to capture        thrombus and remove it from arteries and veins. Thus, the        proximal and distal elements can move relative to each other        allowing capture and mechanical removal of material.    -   In some embodiments, the retrieval device can effectively be        manually expanded into thrombus to capture material within a        geometric shape (proximal element and/or distal element) itself        prior to material extraction. In other words, the retrieval        device can trap thrombus within the confines of the proximal        and/or distal elements allowing for mechanical removal of        thrombus.    -   In some embodiments, the distal element can independently        invaginate on itself (to form a chalice) in order to capture        embolic material mechanically. The distal element envelopes the        embolic material when inverted and then when flattened, the        embolic material is exposed. In other words, the distal element        encloses at least a portion of the clot material by inverting a        portion of the distal element.    -   In some embodiments, each geometric shape (proximal and distal        elements) is configured to independently apply a pull force        capable of removing, scraping, or dislodging clot material from        a vessel wall thereby minimizing a need for aspiration. Thus, in        some embodiments, the retrieval device enables removal of        thrombus with minimal reliance on aspiration.    -   In some embodiments, both geometric shapes (proximal and distal        elements) can be collectively used to apply a compressive force        (on a thrombus) ranging from 0 Newtons to 60 Newtons, preferably        in a range of 9 Newtons to 15 Newtons.    -   In some embodiments, the geometric shapes (proximal and distal        elements) are configured to exert the radial, compressive, and        pull forces using atraumatic surfaces.    -   In some embodiments, the retrieval device enables the geometric        shapes (proximal and distal elements) adjusted so that a wide        range of vessel lumen diameters can be treated using a single        adjustable device.    -   In some embodiments, the retrieval device anchors itself        distally to provide for a more stationary wire that improves the        ability to advance catheters into distal anatomy and through        tortuous vasculature.    -   In a preferred embodiment, the retrieval device does not rely on        or require passive expansion of a self-expanding material in        order to perform its thrombectomy functions. In other words, the        geometric shapes (proximal and distal elements) expand reliably        and mechanically to a particular diameter and a particular        radial force, thereby allowing trapping and curettage of        material from the vessel lumen and wall.    -   In some embodiments, the retrieval device utilizes its        adjustable radial forces and its adjustable size to actively        curettage the wall of an artery or vein.    -   In some embodiments, the retrieval device enables removal of        thrombus by simultaneously capturing, compressing, dragging and        curetting thrombotic material from vessel walls. In other words,        the fore and aft (forward and backward) movement of the proximal        element relative to the distal element enables curettage to        separate and mobilize thrombus from vessel wall.    -   In some embodiments, the retrieval device can be used equally as        well and in the same manner for extraction of acute, sub-acute        and organized chronic thrombus in any anatomic location.    -   In some embodiments, the retrieval device includes a completed        aspiration system.    -   In some embodiments, the retrieval device is capable of        performing mechanical removal of PE and DVT.    -   In some embodiments, the single retrieval device is configured        to perform both PE and DVT procedures.    -   In embodiments, the retrieval device minimizes blood loss and        tPA during extraction of thrombus from a vessel lumen.    -   Braid wire parameters for proximal and distal elements—in some        embodiments, each of the proximal and distal elements is a        geometric mesh structure of braid wire. In some embodiments, a        braid includes 32 wires of 0.006 inches diameters each, 8 Pics        (or PPI) per inch, of super elastic Nitinol and pattern: two        over two under—resulting in mesh structure having a cell size of        0.92 inches×0.92 inches.

In various embodiments, following are some of the key parameters of thebraid wire forming the geometric mesh structures (having a plurality ofcells) of the proximal and distal elements:

-   -   Braid diameters: ranging from 3 mm to 20 mm and up to 30 mm in        some embodiments    -   Number of wires: in various embodiments a braid includes 16, 24,        32 or 48 wires    -   Wire diameter: in various embodiments, a diameter of a wire in a        braid ranges from 0.002 inches to 0.02 inches.    -   Wire shape: in various embodiments, a shape of a wire in a braid        includes square, rectangular or triangular (any of these shaped        wires may be twisted for additional cutting surfaces).    -   Wire material: Nitinol, Stainless Steel    -   Patterns: over one under one, one under over two and two over        two under.    -   Pics (or PPI) per inch: ranges from 6 to 16 in various        embodiments.    -   Cell size in a mesh structure: in various embodiments, a cell        size of a mesh structure varies according to the Pics per inch        as follows:

Cell Size Pics Per Inch (inches × inches) 8 .092 × .092″ 9 .072 × .072″10 .065 × .065″ 12 .051 × .051″

Exemplary Live Animal Experimentation Using a Retrieval Device of thePresent Specification

A retrieval device, such as the device 2800, 2900 or 3000, of thepresent specification was introduced into venous structures of an 821 blive swine to perform thrombectomy test procedures. Table A summarizesvalues of a plurality of parameters associated with the test procedures.Once a tip portion was positioned for removal of an occlusion within thevenous structures, proximal and distal elements were expanded, theproximal element slid to dislodge the occlusion and thereafter trappedbetween the proximal and distal elements (in accordance with the methodof FIGS. 31A and 31B).

A first test procedure was performed in the animal's right internaljugular vein (RIJV) having an initial diameter of 4.5 mm. During thefirst test, a handle force of 15.1 N was applied, the distal element wasexpanded to a diameter of 5 mm to exert a radial force of 13 N on thewalls of the RIJV. After the first test, a post test diameter of theRIJV was measured to range between 4 mm and 5 mm.

A second test procedure was performed in the animal's left internaljugular vein (LIJV) having an initial diameter of 5 mm. During thesecond test, a handle force of 15 N was applied, the distal element wasexpanded to a diameter of 8 mm to exert a radial force of 13 N on thewalls of the LIJV. After the second test, a post test diameter of theLIJV was measured to be 5 mm.

A third test procedure was performed in the animal's right externaljugular vein (REJV) having an initial diameter of 8 mm. During the thirdtest, a handle force of 10 N was applied, the distal element wasexpanded to a diameter of 11 mm to exert a radial force of 10 N on thewalls of the REJV. After the third test, a post test diameter of theREJV was measured to range between 8 mm and 9 mm.

A fourth test procedure was performed in the animal's left externaljugular vein (LEJV) having an initial diameter of 9 mm. During thefourth test, a handle force of 11 N was applied, the distal element wasexpanded to a diameter of 11 mm to exert a radial force of 11 N on thewalls of the LEJV. After the fourth test, a post test diameter of theLEJV was measured to range between 7 mm and 8 mm.

A fifth test procedure was performed in the animal's right common iliacvein (RCIV) having an initial diameter of 14 mm. During the fifth test,a handle force of 7 N was applied, the distal element was expanded to adiameter of 16 mm to exert a radial force of 14 N on the walls of theRCIV. After the fifth test, a post test diameter of the RCIV wasmeasured to be 14.5 mm.

A total of 5 retrieval device cycles, where each cycle comprisesexpanding the proximal element, capturing material, moving the proximalelement, pulling out the material and moving the proximal element back,were performed in each of the first, second, third, fourth and fifthtest procedures.

TABLE A Test 1 2 3 4 5 Location RIJV LIJV REJV LEJV RCIV Handle 3.4 lbs3.4 lbs 2.2 lbs 2.5 lbs 1.5 lbs Force (15.1 N) (15 N) (10 N) (11 N) (7N) Radial Force 13 N 13 N 10 N 11 N 14 N Vessel 4.5 mm 5 mm 8 mm 9 MM 14mm Initial Diameter Sphere 5 mm 8 mm 11 mm 11 MM 16 mm Expanded DiameterCycles 5 5 5 5 5 Post Test 4-5 mm 5 mm 8-9 mm 7-8 mm 14.5 mm VesselDiameter

Post procedures, H&E staining of the cross-sections of the venousstructures (RIJV, LIJV, REJV, LEJV and RCIV) were performed by aveterinary pathologist as part of a histopathology study that used aleft iliac vein as control vessel. Table B summarizes results of thepathology evaluation, as follows:

TABLE B File ID Vessel ID Pathology Evaluation 1056122 #1 Left IliacLinear tangential section of blood vessel: Normal vasculature Vein(control vessel) 1056125 #2 Right Linear tangential sections of bloodvessel: The several sections Common Iliac of tangential blood vesselsappear normal with post-mortem Vein blood pooling. Scattered loss ofendothelial lining in some of the vessels. (experimental vessel) 1056123#3 Left External Linear tangential sections of blood vessel: The severalsections Jugular Vein of tangential blood vessels appear normal withsome post- mortem blood pooling. (experimental vessel) 1056077 #4 LeftInternal Linear tangential sections of blood vessel: The severalsections Jugular Vein of tangential blood vessels appear normal withpost-mortem blood pooling. Scattered loss of endothelial lining in someof the vessels. (experimental vessel) 1056121 #5 Right External Lineartangential sections of blood vessel: The several sections Jugular Veinof tangential blood vessels appear normal and are expanded by pooling ofblood and early fibrin clot formation. Scattered loss of endotheliallining in some of the vessels. (experimental vessel) 1056079 #6 RightInternal Linear tangential sections of blood vessel: The severalsections Jugular Vein of tangential blood vessels appear normal withsome pooling of blood and early fibrin clot formation. Scattered loss ofendothelial lining in some of the vessels. (experimental vessel)

In all specimens, the vascular integrity was intact and the histology ofvascular elements essentially normal. The blood pooling and clottingwere observed to be recent events and were considered to be artifactualas there was no definitive pathology associated with the veins. In someof the blood vessels, there was scattered endothelial cell loss, whichwas considered most likely also artifactual and due to venous extractionand handling. As an example, FIG. 36B illustrates a linear tangentialsection of the right iliac vein 3604 of the animal after a testprocedure, in comparison to FIG. 36A that illustrates a lineartangential section of the left iliac vein 3602 that has not beensubjected to the thrombectomy test procedure. FIG. 36B is illustrativeof a normal vascular histology when compared with the histology of thevein (control vessel) of FIG. 36A.

Experimental Use Case Study 1

FIG. 39A shows a linear continuous flow model 3905 representative of ablood vessel for performing experimental thrombectomy using a retrievaldevice, in accordance with some embodiments of the presentspecification. The model 3905 has a proximal access hemostatic valvedport that permits introduction of an aspiration catheter and a deliverycatheter (such as, the aspiration catheter 2835 and delivery catheter2848 of FIG. 28A). The model 3905 also includes a distally locatedfilter or collection trap that can capture distal emboli that occurduring thrombectomy.

The model 3905 allows incorporation of a pre-made tube, of a predefinedinternal diameter, with mechanically characterized artificial thrombusspliced into the tube. A pre-made tube with artificial thrombus is alsoreferred to collectively as a ‘cartridge’. FIG. 39B shows examplecartridges consisting of tubes 3910, 3912, 3914, 3916 and 3918 withartificial thrombus 3911, 3913, 3915, 3917 and 3919, respectively. Inembodiments, an artificial thrombus is manufactured using apredetermined recipe of egg albumin, flour, water and food coloring. Themodel 3905 further includes pressure transducers proximal and distal toa cartridge incorporated in the model 3905.

For the experimental use case study:

-   a) Fifteen cartridges are prepared such that each cartridge has a    tube of 15 mm diameter and artificial thrombus or clot spliced into    the tube. Weight of each of the empty tube cartridge (that is,    without the thrombus) is recorded.-   b) The fifteen cartridges are organized into first, second and third    groups such that each group includes five cartridges.-   c) The five cartridges of the first group are exposed to a microwave    oven for 15 seconds, the five cartridges of the second group are    exposed to a microwave oven for 30 seconds, and the five cartridges    of the third group are exposed to a microwave oven for 45 seconds.    Weight of each of the cartridges with microwaved thrombus is    recorded.-   d) Each of the fifteen cartridges with the microwaved thrombus is    submerged in water for 30 minutes to saturate the microwaved    thrombus with fluid. Weight of each of the cartridges with water    saturated microwaved thrombus is recorded. Using, the weight of the    empty tube cartridge and weight of the microwaved and water    saturated cartridge, the approximate saturated thrombus weight is    determined for each cartridge.-   e) Modulus of Elasticity of the experimental artificial thrombus in    each cartridge is determined after it is saturated. It should be    appreciated, that each of the thrombi of the first group of five    cartridges will have a first Modulus of Elasticity, each of the    thrombi of the second group of five cartridges will have a second    Modulus of Elasticity, and each of the thrombi of the third group of    five cartridges will have a third Modulus of Elasticity. The third    Modulus of Elasticity will be greater than the second Modulus of    Elasticity which will be greater than the first Modulus of    Elasticity. Thus, each group will have similar Modulus of Elasticity    that increases from the first group through the second group and to    the third group.-   f) Place a cartridge into the non-pulsatile flow model 3805 that has    a pressure transducer positioned proximal and distal to the    occlusive thrombus cartridge.-   g) The aspiration catheter is inserted through the hemostatic valve    and positioned proximal to the thrombus cartridge.-   h) The delivery catheter is inserted into the thrombus.-   i) A pump, associated with the flow model 3905, is switched on in    order to generate fluid flow through the model 3905.-   j) Baseline pressures are measured proximal and distal to the    occlusive thrombus cartridge.-   k) A retrieval device (such as, the device 2800, 2900 or 3000) is    inserted into the delivery catheter.-   l) A tip portion of the retrieval device is unsheathed and a timer    is started.-   m) An operator now uses the retrieval device to extract the thrombus    or clot. A continuous video recording is done of the thrombus    extraction process in the tubing.-   n) During the thrombus extraction process continuous pressure    monitoring is performed both distal and proximal to the cartridge.-   o) The timer is stopped when the thrombectomy is clinically    completed.

Steps f) through o) are repeated for each of the fifteen cartridges.

The following exemplary data is derived as a result of the experimentalsteps performed above:

-   -   Time from deployment of the retrieval device in the        thrombus/clot to clinical thrombectomy completion.    -   Time to achieve clinically significant pressure equalization        across the thrombosed cartridge.    -   Mass by weight of the extracted thrombus/clot. This mass divided        by the baseline clot mass will provide a percentage of clot that        was removed by the retrieval device in a specific time.    -   Mass by weight of the distally embolized thrombus/clot that was        captured by the filter. This mass divided by the baseline        thrombus/clot mass will provide a percentage of the        thrombus/clot that embolized distally during the thrombectomy        procedure.

Steps a) to o) are repeated for first and second prior art devices togenerate data comparable to the data pertaining to the retrieval deviceof the present specification. When compared with data of the first andsecond prior art devices, the retrieval device does the following:

-   -   Extracts thrombus/clot faster    -   Re-establishes acceptable pressure differences faster    -   Removes more thrombus/clot    -   Produces less distal embolization

In some embodiments, additional cartridges are prepared that haveincreasing Moduli of Elasticity of the artificial thrombi. Thereafter,the retrieval device is separately deployed in each of the additionalcartridges until a point of failure is reached—that is, the point whereit is no longer possible to manually expand the proximal and distalelements and remove thrombus/clot material. The same approach isfollowed for the first and second prior art devices. Compared to thefirst and second prior art devices, the retrieval device of the presentspecification can open in thrombus/clot material that has a far greaterModulus of Elasticity than can the first and second prior art devices.

Experimental Use Case Study 2

This study uses a closed-loop anatomical flow model for performingexperimental thrombectomy using a retrieval device of the presentspecification (such as, the device 2800, 2900 or 3000). The flow modelhas a proximal access hemostatic valved port that permits introductionof an aspiration catheter and a delivery catheter (such as, theaspiration catheter 2835 and delivery catheter 2848 of FIG. 28A). Themodel also includes a distally located filter or collection trap thatcan capture distal emboli that occur during thrombectomy.

The model allows incorporation of a pre-made tube, of a predefinedinternal diameter, with mechanically characterized artificial thrombusspliced into the tube. A pre-made tube with artificial thrombus is alsoreferred to collectively as a ‘cartridge’. In embodiments, an artificialthrombus is manufactured using a predetermined recipe of egg albumin,flour, water and food coloring. In accordance with an embodiment, thestudy uses an artificial thrombus, having a Modulus of Elasticity, thatcan be extracted by the retrieval device of the present specificationbut not by first and second prior art devices. The model furtherincludes pressure transducers proximal and distal to a cartridgeincorporated in the model.

For the experimental use case study:

-   a) A video recording is made of the thrombus/clot extraction    procedure and of the thrombus/clot distal embolization.-   b) Measure pressures during the procedure.-   c) Measure resistance to device extraction once it is deployed    against a native PA (Pulmonary Artery) vessel wall that does not    have clot in it.-   d) Record the volume of fluid aspirated from the aspiration catheter    during thrombus extraction. The aforementioned study is repeated for    the first and second prior art devices.    Comparative Studies of a Retrieval Device of the Present    Specification with Respect to First and Second Conventional Devices

In the foregoing studies, the retrieval device of the presentspecification refers to any of the devices 2800, 2900 or 3000. Theforegoing studies are directed towards comparative abilities of theretrieval device of the present specification with respect to the firstand second prior art devices to extract thrombus material that simulatessub-acute and organized thrombus encountered in Pulmonary Embolism(PE)/Deep Vein Thrombosis (DVT) clinical settings.

FIG. 40A shows first, second and third views 4002, 4004 and 4006illustrating deployment capability of a retrieval device 4010 of thepresent specification with respect to first and second prior art devices4020 a, 4020 b. View 4002 shows the retrieval device 4010 with proximaland distal elements in collapsed state 4012 a, 4013 a and in expandedstate 4012 b, 4013 b. As visible, the proximal element 4012 is expandedimmediately inside a hot dog 4015 while the distal element 4013 is keptcollapsed demonstrating independent maneuver capabilities of theproximal and distal elements 4012, 4013.

View 4004 shows the first prior art device 4020 a deployed within thehot dog 4015. The first prior art device 4020 a includes first, secondand third self-expanding Nitinol discs 4022, 4024, 4026. However, noneof the first, second and third discs 4022, 4024, 4026 are able to expandinside the hot dog 4015 despite being deployed for 10 minutes.

View 4006 shows the second prior art device 4020 b deployed within thehot dog 4015. The second prior art device 4020 b includes aself-expanding Nitinol basket 4028. However, the basket 4028 is unableto expand inside the hot dog 4015 despite being deployed for 10 minutes.Thus, the self-expanding Nitinol discs 4022, 4024, 4026 and basket 4028of the first and second prior art devices cannot reliably expand intosub-acute and organized thrombus. Consequently, the discs and basketcannot achieve their designed outer diameters and therefore are unableto generate the radial force needed to extract sub-acute or organizedthrombus. The discs and basket deform around the thrombus therebyfailing to effectively remove it.

FIG. 40B shows first, second and third views 4032, 4034, 4036 of thefirst prior art device 4020 a being sequentially retracted from the hotdog 4015. View 4032 shows the first disc 4022 being removed from the hotdog 4015. The first disc 4022 is unable to achieve its maximum outerdiameter because the other two discs (second and third discs 4034, 4036)are constrained within the hot dog 4015. View 4034 shows the second disc4024 being removed from the hot dog 4015. Both the first and seconddiscs 4022, 4024 are unable to achieve their respective maximum outerdiameters because the remaining third disc 4026 is still constrainedwithin the hot dog 4015. View 4036 shows the third disc 4026 beingremoved from the hot dog 4015. Since none of the three discs areconstrained, now each disc is able to achieve its designed maximum outerdiameter.

It is observed from the study of FIG. 4B that the first prior art device4020 a is a contiguous three-disc design inter-connected by two bandswhere the diameter of one disc affects the diameter of the adjacentdisc. If the device 4020 a is placed into firm or heterogeneous thrombusand one disc cannot open to its full discoid shape, then the other discscannot fully expand as well. Thus, unlike the retrieval devices of thepresent specification, the three discs 4022, 4024, 4026 of the firstprior art device 4020 a are not functionally independent and cannotgenerate the radial force and fore/aft movement needed to removeorganized fibrotic thrombus.

FIG. 40C shows first, second and third views 4042, 4044, 4046illustrating a comparison of thrombectomy capabilities of the firstprior art device 4020 a, the second prior art device 4020 b and theretrieval device 4010 of the present specification. The thrombectomycapabilities refer to the comparative abilities of the devices toextract thrombus material that simulates sub-acute and organizedthrombus encountered in Pulmonary Embolism (PE)/Deep Vein Thrombosis(DVT) clinical settings.

View 4042 shows the first prior art device 4020 a having failed toremove thrombus material (hot dog) due to its self-expanding Nitinoldiscs being unable to generate the radial force required to expand intothe thrombus material. View 4044 shows the second prior art device 4020b having failed to remove thrombus material (hot dog) due to itsself-expanding Nitinol basket being unable to generate the radial forcerequired to expand into the thrombus material. View 4046 shows theretrieval device 4010 of the present specification being able to expandinto organized thrombus (hot dog) and remove a significant amount ofthrombus material 4048 due to the mechanical properties/characteristicsof the retrieval device 4010.

Following are key take away from the studies of FIGS. 40A, 40B and 40C:

-   a) Self-expanding nitinol disc/basket design of the first and second    prior art devices cannot reliably expand into subacute and organized    thrombus, failing to remove material as the radial force is    inadequate.-   b) Self-expanding nitinol disc/basket of the first and second prior    art devices achieves maximum radial force only if the disc/basket    expands/forms to the deigned maximum Outer Diameter (O.D.). If    disc/basket is partially opened, it will not generate the radial    force to remove organized thrombus and will deform around the    organized clot, failing to mechanically remove it.-   c) Active, controlled radial expansion of proximal and distal    elements of the retrieval device of the present specification into    organized clot, with independent movement of the proximal and distal    elements axially, provides the needed radial force and mechanical    potential to remove organized fibrotic thrombus.

Thus, the retrieval device of the present specification is characterizedby at least the following:

-   -   The proximal and distal elements can reliably expand and deploy        on all thrombi.    -   The proximal and distal elements can expand and deploy in firm        subacute and chronic thrombus.    -   Includes two thrombectomy elements (proximal and distal) in a        single insertion.    -   The proximal and distal elements can be deployed/expanded        independently of one another.    -   The proximal and distal elements can be simultaneously deployed        at different diameters with the diameters controlled by the        operator.    -   Each of the proximal and distal elements can move independent of        the other.    -   The proximal and distal elements can be moved fore and aft        within a vessel lumen to curettage thrombus from the vessel        wall.    -   Multiple passes can be conducted by the proximal and distal        elements without re-sheathing the retrieval device.    -   Diameters of the proximal and distal elements can be actively        controlled and adjusted while also moving fore and aft.    -   The retrieval device provides actively controlled wide range of        proximal and distal element diameters, permitting access to both        small and large diameter vessels.    -   The retrieval device can actively capture and extract thrombus        using the device apposition (compress, capture and remove).    -   The retrieval device provides distal embolic protection during        active thrombectomy.    -   The retrieval device does not depend on aspiration to extract        thrombus.    -   The retrieval device is not tPA dependent.    -   The retrieval device is proved to function atraumatically in        porcine venous structures based on post procedure histologic        microscopic analysis of vessel.    -   The retrieval device is proven to effectively extract thrombus        from porcine pulmonary arterial system in live animal studies.

A Retrieval Device Having a Single Element/Member

In some embodiments, a retrieval device of the present specification isconfigured to have a single element that has a three-dimensional shapeand is mounted on a tip portion of the device. In some embodiments, theelement takes a substantially spherical shape during an intermediateexpanded state. When fully expanded, the element forms a chalice or cupshape. In some embodiments, the tip portion includes a first tube thatis proximal to a handle of the device and a second tube that is distalto the handle of the device. In some embodiments, the first tube isconfigured to axially telescope into the second tube. In someembodiments, the element is a Nitinol mesh that has a proximal end and adistal end. The proximal end is coupled to the first tube and the distalend is coupled to the second tube.

In some embodiments, when a first knob, slider or button is slid forwardtowards the tip portion, the first tube moves axially into the secondtube and the proximal end of the element moves distally (while thedistal end of the element remains stationary) causing the element toexpand into a substantially spherical shape. As the first knob or buttonis slid forward further, the proximal end of the element moves furtherclose to the stationary distal end causing the element to take on a cupor chalice shape. Similarly, when the first knob or button is slidbackward away from the tip portion, the first tube moves axially out ofthe second tube and the proximal end of the element moves proximally(while the distal end of the element remains stationary) causing theelement to contract into a substantially cylindrical shape.

In some embodiments, when a second knob or button is slid forwardtowards the tip portion, the first and second tubes move distallytogether as one and the proximal and distal ends of the element movetogether distally causing the element to move distally away from thehandle. Similarly, when the second knob or button is slid backward awayfrom the tip portion, the first and second tubes move proximallytogether as one and the proximal and distal ends of the element movetogether proximally causing the element to move proximally towards thehandle. Thus, sliding the second knob or button forward causes theelement to move forward or distally while sliding the second knob orbutton backward causes the element to move backward or proximally.

FIG. 41A illustrates a retrieval device 4100, in accordance with someembodiments of the present specification. The device 4100 comprises afirst unit 4190 that includes a handle 4102 coupled to a tip portion4104 via telescoping tubes wherein the handle 4102 is configured tosteer the tip portion 4104 in proximity to an occlusion. The device 4100further comprises a second unit 4192 that includes an aspirationcatheter 4135 having a syringe 4137, a one-way valve 4139 and a port4142, where the port is coupled to a proximal end 4144 of the aspirationcatheter 4135. In one embodiment the one-way valve is configured todirect suction through the aspiration catheter 4135. For use during aprocedure, the tip portion 4104 is placed into a delivery catheter 4148and thereafter the delivery catheter 4148 is inserted into theaspiration catheter 4135, and follows through to port 4142, so that atleast the tip portion 4104 projects distally from a distal end 4146 ofthe aspiration catheter 4135.

In accordance with aspects of the present specification, the device 4100is configured to enable an operator to single-handedly operate/actuatethe handle portion 4102 in order to mechanically expand, contract, ormove a member 4106. In one embodiment, a first slider, knob, button, orother actuation mechanism 4114 is configured to mechanically expand ormechanically contract the member 4106. The handle portion 4102 isfurther moved fore and aft to cause the tip portion 4104 and thereforethe member 4106 to be moved fore and aft in order to curettage theocclusion. In another embodiment, an optional second slider, knob,button, or other actuation mechanism 4120 is configured to axially movethe member 4106 relative to the tip portion 4104. In one embodiment, thefirst slider, knob, button, or other actuation mechanism 4114 and thesecond slider, knob, button, or other actuation mechanism 4120 arepositioned in an arc around an external surface of the handle such thateach of the first and second actuation mechanisms are at the samelocation, or within 3 inches, axially along the length of the handle.

In another embodiment, the handle 4102 comprises one or more actuationmechanisms to deliver medications and, in particular, deliver tPA(tissue Plasminogen Activator) and/or activate an aspiration. In oneembodiment, a method of treatment would include infusing tPA into atleast one lumen positioned within the catheter 4148. Preferably theinfusion is performed at the outset of the pulmonary embolism or deepvein thrombosis treatment process, while the member 4106 is still housedwithin the catheter 4148, thereby covering the unexpanded member 4106 intPA. Alternatively, the infusion is performed at the outset of thepulmonary embolism or deep vein thrombosis treatment process, while themember 4106 is still housed within the catheter 4148, directed through adistal end of the catheter 4148, and injected directly into the clotprior to inserting and expanding the member 4106.

In another embodiment, the catheter and handle, in combination, areconfigured to deliver ultrasonic energy to a clot in order to acceleratelytic dispersion, drive medications deeper into the clot, speed thebreakdown of the clot, and/or degenerate or unwind the fibrin quicker.In one embodiment, the catheter comprises an ultrasonic core in parallelwith the elongated wire extending axially through the catheter lumen.The ultrasonic core is in electrical communication with a control unitpositioned external to the catheter. A proximal end of the handle wouldpreferably have one or more leads in electrical communication with theultrasonic core that would extend outward from the handle and beconfigured to connect to the control unit. During the pulmonary embolismor deep vein thrombosis treatment process, the ultrasonic energy wouldbe activated, using the control unit, at the beginning of the treatmentupon delivery of the medications, as described above.

In embodiments, an ultrasonic core energy generator runs through thecenter of the catheter. In embodiments, the ultrasonic core energygenerator includes a control unit configured to manage the generator. Aproximal end of the handle includes leads plug into the control unit, inembodiments.

In accordance with some aspects of the present specification, the firstand second units 4190, 4192 are manufactured as separate standaloneunits or devices. This is advantageous in that a physician may use thefirst unit 4190 with any third-party aspiration catheter. In someembodiments, the aspiration catheter 4135 is available with a pluralityof external diameters such as, but not limited to, 12 Fr, 16 Fr, 20 Fr,and 24 Fr (where Fr represents French scale or gauge system). In someembodiments, the syringe 4137 has an exemplary, non-limiting, volume of60 cubic centimeters.

In some embodiments, for use in treatment of pulmonary embolism a lengthof the delivery catheter 4148 is in a range of 80 cm to 160 cm,preferably 120 cm. In some embodiments, for use in treatment ofpulmonary embolism the aspiration catheter 4135 has different lengthsfor different external diameters. For example, an aspiration catheter of16 Fr has a length in a range of 70 cm to 160 cm, preferably 112 cm, anaspiration catheter of 20 Fr has a length in a range of 60 cm to 150 cm,preferably 106 cm, and an aspiration catheter of 24 Fr has a length in arange of 50 cm to 130 cm, preferably 90 cm. In some embodiments, for usein treatment of deep vein thrombosis a length of the delivery catheter4148 is in a range of 40 cm to 120 cm, preferably 80 cm. In someembodiments, for use in treatment of deep vein thrombosis a length of a16 Fr aspiration catheter 4135 is 65 cm. In some embodiments, for use intreatment of right heart/atrium, the aspiration catheters can range from24 Fr with a length of 90 cm to 28 Fr with a length of 70 cm. In someembodiments, for use in treatment of IVC/SVC (Inferior VenaCava/Superior Vena Cava), the aspiration catheters can range from 24 Frwith a length of 90 cm to 28 Fr with a length of 70 cm. In someembodiments, at least one pressure transducer or sensor 4109 (such as,for example, a fiber-optic pressure sensor, electro-mechanical pressuresensor and hydraulic pressure sensor) is positioned at a distal end ofaspiration catheter 4135. In some embodiments, the at least one pressuretransducer or sensor 4109 is in the form of an elongated member that isco-extruded into the aspiration catheter 4135 so that the elongatedmember runs along a full length of the aspiration catheter 4135. Inembodiments, the pressure transducer or sensor 4109 is in electricalcommunication with electronic circuitry located in a handle 4102 of thefirst unit 4190. In embodiments, the handle 4102 includes a pressuredisplay 4121. In various embodiments, the pressure transducer or sensor4109 is configured to sense a pressure change or drop and, inparticular, provide the physician with an indication that, as theocclusion is removed, there is an associated change of pressureindicative of a right side drop in right heart pressure. A right sidedrop in right heart pressure indicates that a problematic occlusion isbeing successfully removed.

In embodiments, the tip portion 4104 has a proximal end 4150 and adistal end 4152. During operation of the device 4100, the tip portion2804 is inserted into, for example, a blood vessel for removing anocclusion while the handle portion 4102 remains in an operator/user'shands. During insertion of the device 4100 into the blood vessel, thedistal end 4152 of the tip portion 4104 enters the blood vessel firstand is placed in close proximity to the occlusion within the bloodvessel by using the handle 4102 to maneuver the insertion of the tipportion 4104 in a desired position in the blood vessel. The tip portion2804 comprises the member, element or body 4106, which in an embodimentis a mechanically expandable pusher ball that is slidably mountedproximate the proximal end 4150 of the tip portion 4104. The mechanicalexpansion is in contrast to a non-mechanical expansion occurring becausea shape memory material is naturally configured to adopt a pre-definedshape without mechanical force requiring to be applied.

In various embodiments, element 4106 is a substantially curvedstructure. In some embodiments, the element 4106 is a three-dimensional(3D) shape. In one embodiment, the element 4106 is a braided structuremade of interwoven wires such that the structure has a plurality of openareas (allowing egress from outside the element into the internal volumeof the element) formed by the braid. The open areas, relative to thetotal surface area of the element 4106 is in a range of 1% to 99% of thetotal surface area. In one embodiment, the element 4106 has a highpercentage of open surface area thereby allowing the element 4106 tocapture more clot material. The element 4106 may be of any shape,including spherical, elliptical, conical, polygonal, cylindrical, stent,chalice cup, umbrella, concave structure, convex structure, half-sphere,sphere, windsock, dumbbell, star, polygon, lever or a combination ofsuch shapes.

In one embodiment, as shown in FIGS. 41B and 41C, the element 4106 isstructurally shaped as a first funnel 4186 having a neck 4188 directedalong a longitudinal axis of the tip portion 4104 in a proximaldirection and a second funnel 4187 having a neck 4189 directed along theaxis in a distal direction wherein the cup edge of the first funnel 4186and the second 4187 are attached (in the form of contiguous wires)across a center axis 4191. In some embodiments, when the element 4107 ismechanically expanded, a proximal portion and a distal portion of theelement expands first followed by a center portion. In some embodiments,each of the respective proximal, distal and center portions of theelement 4106 may expand at different rates. In some embodiments, theelement 4106 may be heterogeneous, having different characteristicsincluding, without limitation, radial force, shape, size (for example,thickness, diameter), pore size (for example, mesh pore size or openareas as described above), and external coating.

Referring back to FIG. 41A, the tip portion 4104 is at least partiallyenclosed within the delivery catheter 4148 which when retracted exposesthe element 4106 when the device 4100 is inserted and maneuvered withinthe vascular system or non-vascular structures, by using the handleportion 4102.

In some embodiments, the tip portion 4104 comprises at least twoflexible telescoping tubes, that when manipulated together enable anoperator/doctor to expand or contract the element 4106 and move theelement 4106 axially, in order to dislodge and remove the occlusion.

In some embodiments, the element 4106 is fabricated from a Nitinol wiremesh having a plurality of mesh pores, lattices or cells. In some lesspreferred embodiments, the element 4106 is an inflatable deviceincluding, but not limited to, an inflatable balloon.

In some embodiments, element 4106 may be characterized by its ability toapply a variable radial force by virtue of the mechanical expansionbeing applied to the structure and the stiffness or rigidity acrosssub-regions of the element 4106. For example, in some embodiments, theexpansion of the element 4106 to a first size (defined by an area orvolume encompassed by the element) may be characterized by a firstradial force that first size can apply to surrounding materials. Theexpansion of the element 4106 to a second size (defined by an area orvolume encompassed by the element that is larger than the first size)may be characterized by a second radial force that second size can applyto surrounding materials, where the second radial force is differentfrom the first radial force. In some embodiments, each of the first andsecond radial forces are in a range of 2 Newtons to 20 Newtons,preferably 4 Newtons to 12 Newtons. The mechanical expansion allows forthe intermittent, controlled expansion of the element 4106 so that itcan adopt and retain the shape of a first size (having a first area orvolume), a second size (having a second area or volume), a third size(having a third area or volume), or a fourth size (having a fourth areaor volume) under the control of the user and throughout the length of aprocedure where the fourth size is bigger than the third size which isbigger than the second size which is bigger than the first size.

In some embodiments, the element 4106 may be characterized by itsability to resist an application of a radial force, thereby maintainingits expanded shape, by virtue of the mechanical expansion being appliedto the structure and the stiffness or rigidity across sub-regions of theelement 4106. For example, in some embodiments, the expansion of theelement 4106 to a first size (defined by an area or volume encompassedby the element) may be characterized by an ability to resist (andtherefore avoid collapse or compression of the first size) from a firstradial force. The expansion of the element 4106 to a second size(defined by an area or volume encompassed by the element that is largerthan the first size) may be characterized by an ability to resist (andtherefore avoid collapse or compression of the second size) from asecond radial force that is different from the first radial force. Insome embodiments, each of the first and second radial forces are in arange of 2 Newtons to 20 Newtons, preferably 3 to 15 Newtons, morepreferably 4 Newtons to 12 Newtons. The mechanical expansion allows forthe intermittent, controlled expansion of the element 4106 so that itcan adopt and retain the shape of a first size (having a first area orvolume), a second size (having a second area or volume), a third size(having a third area or volume), or a fourth size (having a fourth areaor volume) under the control of the user and throughout the length of aprocedure where the fourth size is bigger than the third size which isbigger than the second size which is bigger than the first size. Itshould further be appreciated that the element 4106 is adapted to notcollapse or compress when positioned against blood flow that applies ahydrostatic pressure in a range of 80 mm Hg to 250 mm Hg. This isparticularly valuable in arterial clot removal where the hydrostaticpressure level often causes other structures, particularlyself-expanding structures, to compress or collapse.

In one embodiment, a physician uses any of the embodiments disclosedherein by a) placing the element 4106 into the occlusion, b) expandingthe element 4106 to a diameter, width, or volume that is greater than orequal to the diameter, width or volume of the vessel lumen it ispositioned within of vessel (if greater than, it may be equal to or upto 150%, preferably around 110% to 130%, more preferably 120%), c)moving the element 4106 back and forth to scrape out the occlusion anddirect the scraped occlusion to an aspiration catheter, d) applyingaspiration, e) collapsing the element 4106 to pull it back into thecatheter, with remaining non-aspirated thrombus, and f) removing thecatheter from the patient.

In some embodiments, the element 4106 may have anti-platelet coating toreduce adhesion and provide a less thrombogenic environment duringclinical application. In some embodiments, the element 4106 may becoated with control release agents including, but not limited to,thrombolytic agents.

In embodiments, the tip portion 4104 comprises a plurality oftelescoping tubes, such as at least 2. As shown in FIG. 41B (in anexpanded form), a first tube 4130 projects distally from a distal end ofthe delivery catheter 4148 (FIG. 41A). The first tube 4130 is coupledwith a second tube 4125. The second tube 4125 forms the distal end 4152of the tip portion 4104. In an embodiment, the two tubes 4130 and 4125are arranged as a coaxial array of telescopic tubes, wherein the firsttube 4130 is designed to be able to move axially relative to the secondtube 4125 which is fixed relative to the handle portion 4102. Inembodiments, the first tube 4130 can be axially expanded or contractedrelative to the second tube 4125 by using the handle portion 4102. In anembodiment, the telescoping tubes 4130 and 4125 are made of Nitinol.

In an embodiment, the element 4106 has a proximal end 4160 and a distalend 4162. The distal end 4162 of the element 4106 is fixedly attached tothe second tube 4125 at a point 4128, while the proximal end 4160 isfixedly attached to the first tube 4130 at a point 4129 in both expandedand non-expanded states of the element 4106. In various embodiments, ina non-expanded state, the element 4106 (comprising a plurality of wires)forms a wire mesh 4126 concentrically positioned around a lumen of thesecond tube 4125.

In embodiments, a portion of the wire mesh 4126 is only attached atpoints 4128 and 4129, of an exterior surface of the second tube 4125 andthe first tube 4130, respectively, while the remaining portion of thewire mesh 4126 is unattached and therefore free to expand or contract.Upon axial compression of the first tube 4130 relative to the secondtube 4125, the wire mesh 4126 is induced to expand radially around thelumen of the second tube 4125. Similarly, upon axial decompression ofthe first tube 4130 relative to the second tube 4125, the wire mesh 4126is induced to compress or contract radially around the lumen of thesecond tube 4125. Stated differently, relative axial movement of thefirst tube 4130 and the second tube 4125 causes the proximal end 4160 tomove closer to the distal end 4162, whereby the material comprising theelement 4106 and extending between the ends 4160 and 4162 is compressedand therefore expands outward. In contrast, as the proximal end 4160moves away from the distal end 4162, the material comprising the element4106 and extending between the ends 4160 and 4162 is stretched andtherefore collapses down to, and elongates along, a body lumen. Thus,the element 4106 expands by having the proximal end 4160 move distallyand contracts by having the proximal end 4160 move proximally while thedistal end 4162 remains stationary in both cases.

In an embodiment, in an expanded state the element 4106 approximates anelliptical shape wherein, at least a portion of the wire mesh 4126 liesapproximately perpendicular to the lumen of the second tube 4125. In anembodiment, a diameter of an expanded element 4106 is approximately 16mm. In some embodiments, a fully expanded element 4106 is substantiallyelliptical or disc-shaped as shown in FIGS. 41B and 41C, while in atransient or less expanded state the element 4106 may take differentcurved shapes such as, for example, substantially spherical. In someembodiments, a fully expanded element 4106 may be substantiallyspherical shaped while in a transient or less expanded state the element4106 may take a substantially elliptical shape.

As previously discussed, in various embodiments, in an expanded statethe element 4106 may take the form of a cylinder, stent, chalice cup,umbrella, concave structure, half-sphere, sphere, windsock, dumbbell,star, polygon, lever, or any other suitable shape configured for aidingretrieval of the occlusion. In some embodiments, the element 4106 can beturned and rotated as motorized units. In such an embodiment, a smallmotor positioned in or proximate the handle is coupled to the element4106 and, upon actuation, the motor causes the element 4106 to move orrotate.

Referring now to FIGS. 41A and 41D, in an embodiment, the handle portion4102 comprises a groove 4112 running longitudinally along a length ofthe handle 4102. In an embodiment a distance between a distal end 4165of the handle portion 4102 and the distal end 4152 of the tip portion4104 is in a range of 0.5 mm to 110 cm, preferably 1 mm to 100 mm. Thehandle portion 4102 includes a first actuator, knob or button 4114configured to enable the user to mechanically expand or contract theelement 4106. In some embodiments, the element 4106 is moved forward orbackwards, within the occlusion, by moving the handle portion 4102 foreor aft thereby inducing a forward or backward motion of the tip portion4104. In some embodiments, the handle portion 4102 includes an optionalsecond actuator, knob or button 4120 configured to enable the user tomechanically slide the element 4106 forward distally from the handleportion 4102 or backwards proximally towards the handle portion 4102.The first and second knobs 4114, 4120 are slidably fitted into thegroove 4112. The first knob 4114 is coupled with the first tube 4130while the second knob 4120 is coupled with both the first and secondtubes 4130, 4125.

Referring now to FIGS. 41B and 41D, when the first knob 4114 is moved orslid in the groove 4112 towards the tip portion 4104, this causes thefirst tube 4130 to telescope into the second tube 4125, thereby inducingan axial compression of the first tube 4130 relative to the second tube4125. Consequently, the element 4106 is caused to expand to a desireddiameter. When the first knob 4114 is moved away from the tip portion4104 the first tube 4130 is caused to telescope out of the second tube4125 thereby inducing an axial decompression (or elongation) of thefirst tube 4130 relative to the second tube 4125 between the proximaland distal ends 4129, 4128 of the wire mesh 4126. This causes the wiremesh 4126 (and therefore the element 4106) to contract radially aroundthe lumen of the second tube 4125 and assume an unexpanded shape havinga diameter lesser than a diameter in an expanded state or assume a fullyunexpanded state.

When the second knob 4120 is moved in the groove 4112 distally towardsthe tip portion 4104, the element 4106 is caused to slide distally awayfrom the handle 4102, whereas when the second knob 2820 is movedproximally away from the tip portion 4104 the element 4106 is caused toslide proximally towards the handle portion 4102.

In an embodiment, a diameter of a fully expanded element 4106 isapproximately 16 mm. In various embodiments, the element 4106 may expandto a diameter depending upon an application/functional use of the device4100. For example, for use in treatment of a pulmonary/large vesselhaving a diameter of in a range of 20 mm to 30 mm, the diameter of anexpanded element 4106 ranges from 5 mm to 30 mm, preferably 10 mm to 25mm, for use in treatment of a peripheral arterial/DVT vessel having adiameter ranging from 2 mm to 10 mm, the diameter of an expanded element4106 ranges from 3 mm to 12 mm; for use in treatment of neuro vessels,the diameter of an expanded element 4106 ranges from 1 mm to 10 mm; foruse in retrieval of an occlusion in the inferior vena cava (IVC)vessels, the diameter of an expanded element 4106 ranges from 35 mm to40 mm; for use in treatment of biliary ducts, fistula declotting,hepatic bile ducts, brain blood vessels and peripheral arterial vessels(particularly in the hands and feet) having a lumen diameter less than 3mm and even those less than 1 mm, the diameter of an expanded element4106 ranges from 1 mm to 14 mm.

In some embodiments, the diameter of the element 4106, in a fullyexpanded state, ranges from 5 mm to 30 mm, preferably 10 mm to 25 mm,and more preferably 10 mm to 20 mm.

In some embodiments, the first knob 4114 locks (and thus, cannot bemoved further forward) in a position in the groove 4112 when the element4106 has expanded to a maximum diameter. Thus, sliding the first knob4114 forward enables the user to expand the element 4106 to a pluralityof intermediate diameters and up to a maximum permissible diameter. Insome embodiments, the first knob 4114 is provided with a “clutch”feature so that, when opposing pressure is experienced from walls of ablood vessel during expansion of the element 4106, the “clutch” clicksin so that the user does not over expand. This feature is advantageoussince it prevents the user from damaging the blood vessel due to overexpansion of the element 4106.

In some embodiments, the groove 4112 has a series of interlockingfeatures along its length such that the first knob 4114 can beselectively engaged or disengaged from a locked position in the handle4102 at a plurality of expanded diameters for the element 4106.

In some embodiments, the device 4100 utilizes a lead-screw mechanism forcontinuous adjustment of the diameters of the element 4106 so that thefirst knob 4114 may be advanced or retracted to an infinitely variablenumber of positions in the groove 4112 and may be held in a desiredposition by using a friction based locking mechanism, in order for theelement 4106 to attain a desired diameter. In an embodiment, anon-backdriving thread pattern in the lead-screw is used to provide afriction-brake when not actuated by the user, enabling continuousadjustment of the diameters of expanded element 4106. In embodiments,the first knob 4114 may be positioned at several differentlocations/positions along the length of the groove 4112, wherein each ofthe locations/positions corresponds to a different degree of expansionof the element 4106, and hence a different shape of the element 4106.

In an embodiment, by moving the second knob 4120, leading to advancingor retracting of the second tube 4125 and the first tube 4130 togetheras one, the element 4106 may be moved axially fore and aft along the tipportion 4104 in an expanded or collapsed state. In some embodiments, theelement 4106 can be moved axially in a range from 1 mm to 8 cm, andpreferably at least 6 cm.

In some embodiments, the first tube 4130 extends from the handle portion4102 to the element 4106 and is co-axial with the second tube 4125.Referring to FIG. 41B, the anchor nose 4134 provides a termination pointfor the element 4106 and, in an embodiment, performs a secondaryfunction of a radiopaque marker. In various embodiments, diameters ofthe telescoping tubes 4130 and 4125 range from 0.3 mm to 2 mm forneurovascular and peripheral applications, and 1 mm to 5 mm forpulmonary and larger applications.

Referring back to FIGS. 41A through 41D, in an embodiment, in order toretrieve an occlusion from a lumen of a patient, the delivery catheter4148 is positioned near the occlusion (using the handle 4102) and thetip portion 4104 is positioned within, or all the way through, theocclusion. Once the occlusion matter is curetted using the element 4106,the syringe 4137 is actuated to generate suction at an aspiration line4124 and aspirate the occlusion matter through the aspiration catheter4135.

Thus, in various embodiments, the element 4106 expands to a particulardiameter and a particular radial force, thereby allowing trapping andcurettage of thrombus or clot material from a vessel lumen and wall. Insome embodiments, the retrieval device 4100 utilizes its adjustableradial forces and its adjustable size to actively curettage the wall ofan artery or vein. In some embodiments, the retrieval device 4100enables removal of thrombus by simultaneously capturing, compressing,dragging and curetting thrombotic material from vessel walls. In oneembodiment, the element 4106 is configured to capture, and/or contain, asize of clot or thrombus material in a volume range of 0.01 ml to 100ml.

In some embodiments, the handle portion 4102 includes a plurality ofgradations such as, for example and by way of example only, threegradations of low, medium and high, five gradations ranging from low tohigh or eight gradations ranging from low to high. Each gradation isindicative of a corresponding predefined diameter of the element 4106 inexpanded states. The two slide buttons 4114 and 4120 can be actuated toany one of the plurality of gradations and then détente to thatposition.

While in some embodiments, the handle portion 4102 includes two buttons4114 and 4120 to manipulate the element 4106, in alternate embodimentsfewer than two buttons may be used. For example, in some embodiments, aclinician's use of the device 4100 is monitored over a predefined numberof uses or operations of the device 4100 while performing mechanicalthrombectomy procedures. Based on the monitoring, a preferred sequenceof deployment of the element 4106 is determined and data indicative ofthe deployment sequence is stored in a memory (residing within thehandle portion 4102 or remote from the handle portion 4102).

As a non-limiting illustration, the deployment sequence may includeexpanding the element 4106 and then moving the element 4106 axially foreand aft for a cycle of, say, 5 reciprocations. Consequently, a singlebutton (when actuated) is programmed to carry out the deploymentsequence. Of course, in some embodiments, the second button may still beused manually after the deployment sequence has been completed by theprogrammed button. In some embodiments, an Artificial Intelligence (AI)algorithm implements the deployment sequence, once the device 4100 isplaced in-vivo, to automatically expand the element 4106 and/or move theelement 4106 axially.

FIG. 42 is a flowchart of a plurality of exemplary steps of a method4200 of treating peripheral arterial disease (PAD) using the retrievaldevice 4100, in accordance with an embodiment of the presentspecification. In accordance with some embodiments, the method 4200enables removing the occlusion from a lumen having an internal diameterless than 3 mm, and preferably less than 1 mm, wherein the lumen is oneof, but not limited to, biliary ducts, fistula declotting, brain bloodvessels, upper and lower extremities, ureter, appendicular artery andperipheral arterial vessels (particularly in the hands, arms, forearms,thighs, legs and feet).

Referring now to FIGS. 41A and 42, at step 4202, in order to retrieve anocclusion from the lumen of a patient, a guidewire is advanced throughthe lumen of the patient and positioned through the occlusion. At step4204, the aspiration catheter 4135 is advanced over the guidewire suchthat a distal end of the aspiration catheter 4135 is positioned at orproximate the occlusion. At step 4206, the delivery catheter 4148 isadvanced through the aspiration catheter 4135 such that a distal end ofthe delivery catheter 4148 lies proximate the distal end of theaspiration catheter 4135.

At step 4208, the retrieval device 4100 is deployed through the deliverycatheter 4148 so that the distal end 4152 of the tip portion 4104 of theretrieval device 4100, protruding from the delivery catheter 4148 orsheath, is positioned within or all the way through and beyond theocclusion. This ensures that the element 4106, in a compressed ornon-expanded state, is positioned within the occlusion.

At step 4210, the element 4106, positioned within the occlusion, ismechanically expanded to a desired diameter (and therefore, to acorresponding shape and to exert a corresponding radial force). In anembodiment, the first knob 4114 on the handle portion 4102 of theretrieval device 4100 is actuated to cause the wire mesh structure ofthe element 4106 to expand out. In some embodiments, upon expansion, theelement 4106 is configured to resist compression from an applied forcein a range of 0 Newtons to 25 Newtons.

At step 4212, the element 4106 is moved axially (in one or more fore andaft motions) to dislodge and scrape/curettage the occlusion. In someembodiments, the occlusion can also be trapped into the mesh lattices ofthe element 4106 of the retrieval device 4100, for example.

In some embodiments, the handle portion 4102 is moved fore and aft tocause the tip portion 4104 and therefore the element 4106 to be movedfore and aft in order to dislodge and curettage the occlusion. Inanother embodiment, the second knob 4120 is actuated to axially move theelement 4106 relative to the tip portion 4104. In some embodiments, theelement 4106 is configured to be moved axially in a range from 1 mm to 8cm and preferably at least 6 cm.

At step 4214, the dislodged and scraped occlusion is removed oraspirated by applying a negative pressure through the aspirationcatheter 4135. In some embodiments, the fore and aft movement of theelement 4106 further directs the dislodged and scraped occlusion towardsthe aspiration catheter 4135.

At step 4216, the element 4106 is collapsed or compressed. In someembodiments, the first knob 4114 is actuated to cause the element 4106to collapse or compress. Finally, at step 4218, the element 4106, incollapsed or compressed state, is retracted and removed from the lumenof the patient.

Removing Gallstones During an ERCP (Endoscopic RetrogradeCholangio-Pancreatography)

In accordance with some aspects, the retrieval devices of the presentspecification, comprising at least one mechanically expandable element,may be used to remove gallstones during an ERCP procedure.

During an ERCP procedure an endoscope is advanced from a patient'smouth, down the esophagus and into the duodenal section of the smallintestines. Thereafter, the endoscope may be advanced proximate thepatient's bile duct and a catheter is then advanced into the patient'sa) bile duct, b) accessory pancreatic duct, c) main pancreatic duct, d)cystic duct, e) common hepatic duct, f) right hepatic duct, g) lefthepatic duct. A contrasting agent is now injected, using the catheter,into the ducts in order to determine filling defects representative ofocclusion such as stones or growth.

If one or more stones or other sludge are determined to be occluding theduct, a retrieval device of the present specification is advanced, overa wire, so that a tip portion is positioned proximate, into or all theway through the occlusion (depending upon the type of occlusion).Thereafter, the proximal and distal elements are mechanically expandedand maneuvered (using a handle and physically manipulable interfaces onthe handle) to remove the occlusion.

FIG. 44 is a flowchart of a plurality of exemplary steps of removinggallstones by using any of the retrieval devices 2800, 2900 or 3000, inaccordance with an embodiment of the present specification. In someembodiments, the retrieval device is used to perform an ERCP procedurein order to remove a gallstone (hereinafter referred to as an‘occlusion’).

At step 4402, a guidewire is advanced through the lumen of the patientand positioned through the occlusion. At step 4404, an aspirationcatheter is advanced over the guidewire such that a distal end of theaspiration catheter is positioned at or proximate the occlusion. At step4406, a delivery catheter is advanced through the aspiration cathetersuch that a distal end of the delivery catheter lies proximate thedistal end of the aspiration catheter. At step 4408, a retrieval deviceis deployed through the delivery catheter so that a distal elementmounted on a tip portion of the retrieval device is positioned within orall the way through and beyond the occlusion.

At step 4410, the distal element is mechanically expanded to a desireddiameter using a first slider on a handle of the retrieval device. Insome embodiments, the distal element is a mechanically expandable andrigid anchor fixedly attached proximate a distal end of the tip portion.

At step 4412, a proximal element (also mounted on the tip portion) ismechanically expanded to a desired diameter using a second slider on thehandle of the retrieval device.

At step 4414, the proximal element is moved axially (in one or more backand forth motions) along the tip portion to dislodge the occlusion (andcurettage the vessel). In some embodiments, the axial fore and aftmovement of the proximal element results in capturing at least a portionof the occlusion between the proximal and distal elements.

In various embodiments, the anchoring of the rigid distal elementproximate the distal end of the tip portion followed by a mechanicalexpansion of the distal element using the first slider (as opposed to aNitinol temperature-based expansion) provides the distal element arequired minimum degree of rigidity to anchor in place within the lumenand/or preferably wedged into the occlusion. Persons of ordinary skillin the art would appreciate that if the distal element is not rigid andnot solidly anchored, the retrieval device may not have sufficientleverage to dislodge the occlusion.

In some embodiments, the anchoring of the distal element to the tipportion and the occlusion (in embodiment where the distal element ispositioned within the occlusion) while attaining a required degree ofrigidity locks the distal element in a desired location with respect tothe occlusion, and allows the proximal element to move back and forthlongitudinally with respect to the distal element to dislodge theocclusion.

In an embodiment, the distal element is positioned and expanded withinthe occlusion (like a fishing hook), and in another embodiment thedistal element is positioned and expanded distal to (or beyond) theocclusion. In an embodiment the proximal element is expanded proximal to(prior to) or within the occlusion, such that the proximal element canbe moved all the way into the expanded (concave or cup-shaped) distalelement to generate a vice-like grip and trap the occlusion between theproximal and distal elements. In some embodiments, once the occlusion istrapped between the proximal and distal elements, the distance betweenthe proximal element and the distal element may be reduced further suchthat the proximal element moves all the way into or proximate the distalelement.

At step 4416, aspiration is used to concurrently remove at least aportion of the occlusion. In some embodiments, aspiration is performedby applying negative pressure at a proximal end of the aspirationcatheter.

At step 4418, the proximal and distal elements are mechanicallycompressed/collapsed, pulled back and removed from the lumen.

In some embodiments, the portion of the occlusion captured between theproximal and distal elements is removed by pulling out the proximalelement, the portion of the occlusion and the distal element togetherfrom the lumen of the patient.

In some embodiments, a first portion of the occlusion captured betweenthe proximal and distal elements is removed by pulling out the proximalelement, the first portion of the occlusion and the distal element whilea remaining second portion is aspirated using an aspiration catheter. Invarious embodiments, the exact technique of removing the occlusionvaries depending upon factors such as, but not limited to, theanatomical location of the occlusion within the patient's body, and thecomplexity and density of the occlusion. However, in variousembodiments, removal of the occlusion involves some degree of moving theproximal element relative to the distal element to dislodge, trap andaspirate the occlusion.

Removing Renal Calculi (Kidney Stones)

In accordance with some aspects, the retrieval devices of the presentspecification, comprising at least one mechanically expandable element,may be used to remove kidney stones.

In some embodiments, an endoscope is advanced from urethral meatus intoa patient's bladder and then into the ureter. Thereafter, a retrievaldevice of the present specification is advanced into the ureter so thata tip portion is positioned proximate the kidney stone. The proximal anddistal elements are then mechanically expanded and maneuvered (using ahandle and physically manipulable interfaces on the handle) to removethe kidney stone. It should be appreciated, that the retrieval devicemay also be advanced into the patient's renal pelvis to remove/extractstones.

FIG. 45 is a flowchart of a plurality of exemplary steps of removingkidney stones by using any of the retrieval devices 2800, 2900 or 3000,in accordance with an embodiment of the present specification. In someembodiments, the retrieval device is advanced from urethral meatus intoa patient's bladder and then into the ureter. Thereafter, the retrievaldevice is advanced into the ureter so that a tip portion is positionedproximate the kidney stone (hereinafter referred to as an ‘occlusion’).

At step 4502, a guidewire is advanced through the lumen of the patientand positioned through the occlusion. At step 4504, an aspirationcatheter is advanced over the guidewire such that a distal end of theaspiration catheter is positioned at or proximate the occlusion. At step4506, a delivery catheter is advanced through the aspiration cathetersuch that a distal end of the delivery catheter lies proximate thedistal end of the aspiration catheter. At step 4508, a retrieval deviceis deployed through the delivery catheter so that a distal elementmounted on a tip portion of the retrieval device is positioned within orall the way through and beyond the occlusion.

At step 4510, the distal element is mechanically expanded to a desireddiameter using a first slider on a handle of the retrieval device. Insome embodiments, the distal element is a mechanically expandable andrigid anchor fixedly attached proximate a distal end of the tip portion.

At step 4512, a proximal element (also mounted on the tip portion) ismechanically expanded to a desired diameter using a second slider on thehandle of the retrieval device.

At step 4514, the proximal element is moved axially (in one or more backand forth motions) along the tip portion to dislodge the occlusion (andcurettage the vessel). In some embodiments, the axial fore and aftmovement of the proximal element results in capturing at least a portionof the occlusion between the proximal and distal elements.

In various embodiments, the anchoring of the rigid distal elementproximate the distal end of the tip portion followed by a mechanicalexpansion of the distal element using the first slider (as opposed to aNitinol temperature-based expansion) provides the distal element arequired minimum degree of rigidity to anchor in place within the lumenand/or preferably wedged into the occlusion. Persons of ordinary skillin the art would appreciate that if the distal element is not rigid andnot solidly anchored, the retrieval device may not have sufficientleverage to dislodge the occlusion.

In some embodiments, the anchoring of the distal element to the tipportion and the occlusion (in embodiment where the distal element ispositioned within the occlusion) while attaining a required degree ofrigidity locks the distal element in a desired location with respect tothe occlusion, and allows the proximal element to move back and forthlongitudinally with respect to the distal element to dislodge theocclusion.

In an embodiment, the distal element is positioned and expanded withinthe occlusion (like a fishing hook), and in another embodiment thedistal element is positioned and expanded distal to (or beyond) theocclusion. In an embodiment the proximal element is expanded proximal to(prior to) or within the occlusion, such that the proximal element canbe moved all the way into the expanded (concave or cup-shaped) distalelement to generate a vice-like grip and trap the occlusion between theproximal and distal elements. In some embodiments, once the occlusion istrapped between the proximal and distal elements, the distance betweenthe proximal element and the distal element may be reduced further suchthat the proximal element moves all the way into or proximate the distalelement.

At step 4516, aspiration is used to concurrently remove at least aportion of the occlusion. In some embodiments, aspiration is performedby applying negative pressure at a proximal end of the aspirationcatheter.

At step 4518, the proximal and distal elements are mechanicallycompressed/collapsed, pulled back and removed from the lumen.

In some embodiments, the portion of the occlusion captured between theproximal and distal elements is removed by pulling out the proximalelement, the portion of the occlusion and the distal element togetherfrom the lumen of the patient.

In some embodiments, a first portion of the occlusion captured betweenthe proximal and distal elements is removed by pulling out the proximalelement, the first portion of the occlusion and the distal element whilea remaining second portion is aspirated using an aspiration catheter. Invarious embodiments, the exact technique of removing the occlusionvaries depending upon factors such as, but not limited to, theanatomical location of the occlusion within the patient's body, and thecomplexity and density of the occlusion. However, in variousembodiments, removal of the occlusion involves some degree of moving theproximal element relative to the distal element to dislodge, trap andaspirate the occlusion.

In accordance with some aspects, at least one pressure transducer orsensor (such as, for example, a fiber-optic pressure sensor,electro-mechanical pressure sensor and hydraulic pressure sensor) ispositioned at a distal end of an aspiration catheter that is used alongwith a retrieval device of the present specification during variousprocedures related to removal of an occlusion from a vessel lumen. Insome embodiments, the at least one pressure transducer or sensor is inthe form of an elongated member that is co-extruded into the aspirationcatheter so that the elongated member runs along a full length of theaspiration catheter. In embodiments, the pressure transducer or sensoris in electrical communication with electronic circuitry located in ahandle of the retrieval device. The handle includes a pressure display.In various embodiments, the pressure transducer or sensor is configuredto sense a pressure change or drop and, in particular, provide thephysician with an indication that, as the occlusion is removed, there isan associated change of pressure indicative of a right side drop inright heart pressure. A right side drop in right heart pressureindicates that a problematic occlusion is being successfully removed.

The above examples are merely illustrative of the many applications ofthe systems and methods of the present specification. Although only afew embodiments of the present invention have been described herein, itshould be understood that the present invention might be embodied inmany other specific forms without departing from the spirit or scope ofthe invention. Therefore, the present examples and embodiments are to beconsidered as illustrative and not restrictive, and the invention may bemodified within the scope of the appended claims.

We claim:
 1. A device adapted to remove unwanted material from a vesselof a patient, wherein the device comprises: an elongated member having afirst proximal end and a first distal end; a proximal expandable elementhaving a first proximal end point and a first distal end point, whereinthe first proximal end point is attached to a first portion of theelongated member and wherein the first distal end point is attached to asecond portion of the elongated member; a distal expandable elementhaving a second proximal end point and a second distal end point,wherein the second proximal end point is attached to a third portion ofthe elongated member, wherein the second distal end point is attached toa fourth portion of the elongated member, and wherein the first portion,second portion, third portion, and fourth portion represent differentlocations along the elongated member; a handle in physical communicationwith the elongated member, wherein the handle comprises a firstphysically manipulable interface and a second physically manipulableinterface, wherein, when moved, the first physically manipulableinterface is adapted to mechanically expand or contract at least one ofthe proximal expandable element or the distal expandable element andwherein, when moved, the second physically manipulable interface isadapted to move the proximal expandable element without moving thedistal expandable element or move the distal expandable element withoutmoving the proximal expandable element.
 2. The device of claim 1,wherein, when moved, the first physically manipulable interface isadapted to mechanically expand or contract the proximal expandableelement.
 3. The device of claim 2, further comprising a third physicallymanipulable interface, wherein, when moved, the third physicallymanipulable interface is adapted to mechanically expand or contract thedistal expandable element.
 4. The device of claim 1, wherein the secondphysically manipulable interface is a slider configured to be movedaxially along a length of the handle and wherein, upon moving the slideraxially along the length, the proximal expandable element moves whilethe distal expandable element remains stationary.
 5. The device of claim1, wherein the second physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle and wherein,upon moving the slider axially along the length, the distal expandableelement moves while the proximal expandable element remains stationary.6. The device of claim 1, wherein the first physically manipulableinterface is a slider configured to be moved axially along a length ofthe handle and wherein, upon moving the slider axially along the length,the proximal expandable element expands or contracts while a size of thedistal expandable element does not change.
 7. The device of claim 1,wherein the first physically manipulable interface is a sliderconfigured to be moved axially along a length of the handle and wherein,upon moving the slider axially along the length, the distal expandableelement expands or contracts while a size of the proximal expandableelement does not change.
 8. The device of claim 1, wherein the proximalexpandable element comprises a braid having a proximal portion and adistal portion, wherein the braid of the proximal portion is denser orstiffer relative to the braid of the distal portion.
 9. The device ofclaim 8, wherein the proximal portion represents 30-70% of the surfacearea of the proximal expandable element and the distal portionrepresents 70-30% of the surface area of the proximal expandableelement.
 10. The device of claim 1, wherein the distal expandableelement comprises a braid having a proximal portion and a distalportion, wherein the braid of the distal portion is denser or stifferrelative to the braid of the proximal portion.
 11. The device of claim10, wherein the distal portion represents 30-70% of the surface area ofthe distal expandable element and the proximal portion represents 70-30%of the surface area of the distal expandable element.
 12. The device ofclaim 1, wherein the proximal expandable element is defined by a firstbraid structure, wherein the distal expandable element is defined by asecond braid structure, wherein the second braid structure is equivalentto the first braid structure.
 13. The device of claim 1, wherein theproximal expandable element is defined by a first braid structure,wherein the distal expandable element is defined by a second braidstructure, wherein the second braid structure is equivalent to the firstbraid structure rotated 180 degrees.
 14. The device of claim 1, furthercomprising a hub valve and a sheath, wherein the hub valve is defined byan enclosure, a first opening in a first end of the enclosure, a secondopening in a second end of the enclosure, and an actuator extendingupward out of the enclosure and wherein the sheath is coupled to thesecond opening.
 15. The device of claim 14, wherein, when the actuatoris depressed, the hub valve is configured to receive the elongatedmember through the first opening and allow the elongated member to passthrough the second opening and through the sheath.
 16. The device ofclaim 14, wherein, when the actuator is not depressed, the hub valve isconfigured to create a seal around a surface of the elongated member.17. The device of claim 14, further comprising a suction source coupledto a portion of the hub and in pressure communication with the sheath.18. The device of claim 17, wherein the suction source is a syringe. 19.The device of claim 1, wherein the handle further comprises a pinpositioned to block a movement of the first physically manipulableinterface and the second physically manipulable interface, a keyholeaccessible from a side of the handle, and a key configured to pass intothe keyhole and make physical contact with the pin.
 20. The device ofclaim 1, wherein the elongated member comprises a first shaft, a secondshaft, a third shaft, and a fourth shaft and wherein the first shaft isconcentrically positioned around the second shaft, the second shaft isconcentrically positioned around the third shaft, and the third shaft isconcentrically positioned around the fourth shaft.
 21. The device ofclaim 20, wherein the first proximal end point is physically attached tothe first shaft, wherein the first distal end point is physicallyattached to the second shaft, wherein the second proximal end point isphysically attached to the third shaft, wherein the second distal endpoint is physically attached to the fourth shaft.
 22. The device ofclaim 21, wherein the first physically manipulable interface isconfigured to axially move the first shaft while the second shaft, thirdshaft, and fourth shaft remain stationary.
 23. The device of claim 22,wherein the first physically manipulable interface is a sliderconfigured to move axially up and down the handle.
 24. The device ofclaim 21, wherein the first physically manipulable interface isconfigured to axially move the fourth shaft while the first shaft,second shaft, and third shaft remain stationary.
 25. The device of claim24, wherein the first physically manipulable interface is a sliderconfigured to move axially up and down the handle.
 26. The device ofclaim 21, wherein the second physically manipulable interface isconfigured to axially move the first shaft and second shaft togetherwhile the third shaft and fourth shaft remain stationary.
 27. The deviceof claim 26, wherein the second physically manipulable interface is aslider configured to move axially up and down the handle.
 28. The deviceof claim 1, wherein the first physically manipulable interface isconfigured to axially move the first portion to one of a first pluralityof predefined incremented positions while the second portion, thirdportion, and fourth portion remain stationary, wherein each of the firstplurality of predefined incremented positions correspond to causing theproximal expandable element to adopt one of a plurality of differentgeometric shapes, and wherein the plurality of different geometricshapes includes at least two of linear, ellipsoid, spheroid, sphericalor disk-shaped.
 29. The device of claim 21, wherein the first physicallymanipulable interface is configured to axially move the fourth portionto one of a second plurality of predefined incremented positions whilethe first portion, second portion, and third portion remain stationaryand wherein each of the second plurality of predefined incrementedpositions corresponds to causing the distal expandable element to adoptone of the plurality of different geometric shapes.
 30. The device ofclaim 29, wherein, upon adopting one of the plurality of differentgeometric shapes other than the linear shape, the distal expandableelement is adapted to not collapse upon an application of up to 25Newtons of force.